Abstract gastroenterology

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Abstracts

Results: K-ras gene mutation was analyzed in 40 cases (31%). Of these, 18 (45%) were positive, 21 (53%) were negative, and 1 (2%) was non-diagnostic.

Of the 40 patients who were tested for K-ras mutation, 5 went on to have a definitive diagnosis. All 5 cases had pre-malignant lesions - three of which were in patients with a detected K-ras mutation. The remaining two cases tested negative for the mutation, but had cyst fluid CEA values of 11,000 ng/ ml and 2,690 ng/ml. Of the 87 cases where K-ras was not analyzed, 47 (54%) went on to have surgery. Of these, the final pathological diagnoses included 13 (28%) benign lesions and 34 (72%) pre-malignant or malignant lesions. Of the 57 cases where cytology was unavailable or not diagnostic, K-ras analysis was performed 21 times, 6 of which tested positive for the mutation.

Conclusion: All five cases that were analyzed for K-ras mutation and came to a definitive diagnosis showed pre-malignant pathology. Although two of these cases did not detect K-ras mutations, their CEA levels were elevated to well over ten times the upper limit of 192 ng/ml accepted for predicting mucinous cysts. On the other hand, 28% of cases that were not tested for K-ras and came to a definitive diagnosis had benign lesions. The data shown here is insufficient to draw any large-scale conclusions, and further studies on a larger scale are needed. Following these set of patients into the future may also elucidate the behavior of different cysts.

Disclosure: Dr. Wahid Wassef: Boston Scientific - Honorarium

protein antigen, hpaA gene, 0.86-kb DNA fragment, and DNA sequences of 16S ribosomal RNA were used as amplification targets. The IHC was evaluated by a single experienced pathologist.

Results: Prevalence studies in the 325 patients showed 26 patients (8%) were positive for HP on IHC, while 64 patients (19.7%) were positive on PCR testing (p<0.0001, Fisher’s test). Although the IHC testing showed 100% specificity, its sensitivity was a mere 40.63%. PCR testing captured all 26 patients (100% sensitivity) of patients positive on IHC, with no false negatives (100% specificity).

Conclusion: Advances in PCR diagnostics allows a much greater proportion of patients with HP to be diagnosed at the time of EGD. Indeed, IHC only had a sensitivity of 40.6% in diagnosing low-level HP infection, possibly due to changes in HP morphology associated with widespread PPI use. The majority of HP patients, i.e., 38 patients of 64 (59.4%) would have been missed on IHC, and likely labeled FD. Indeed, 38 of the 325 patient cohort (11.7%) would have been misdiagnosed, and be at risk of HP associated complications. Nearly all of these patients experienced significant improvement after standard HP treatment.

PANCREATIC/BILIARY 124 Pancreatic Cysts - A Retrospective Analysis of Our Experience at UMMHC with Focus on Utility of K-Ras Gene Mutation Analysis Edward Belkin, MD, Lloyd Hutchinson, PhD, Ediz Cosar, MD, Jaroslav Zivny, MD, Wahid Wassef, MD, FACG. University of Massachusetts Medical Center, Worcester, MA.

125 Chronic Pancreatitis: What Determines Resource Utilization?

Salman Nusrat, MD, Dhiraj Yadav, MD, MPH, FACG, Klaus Bielefeldt, MD, PhD, FACG. University of Pittsburgh Medical Center, Shadyside, Pittsburgh, PA.

Purpose: Pancreatic cysts, which could represent malignant, pre-malignant, or benign lesions, are being detected more frequently due to improvements in imaging techniques. Although the natural history of cysts is not fully ­understood, accurate characterization of cysts is paramount to optimize patient care. Cyst fluid cytology, CEA marker, and more recently, K-ras gene analysis, have all been used in an attempt to characterize cysts. In this study, we undertook an analysis of our experience at UMMHC over the past seven years with different methods of predicting pancreatic cyst type, focusing specifically on the utility of K-ras gene analysis in improving clinical decision making.

Methods: We requested the medical record numbers of all patients seen at UMMHC over the last seven years who were coded with ICD-9 code 577.2, which represents the diagnosis of pancreatic cyst or pseudocyst. We received 1066 unique cases from October, 2003 through February, 2011. Of these, we included in our study those cases that had K-ras analysis and/or came to a definitive diagnosis (surgical specimen), which included 85 unique cases.

Some of these patients had one or more follow-up EUS exams, which was often accompanied by cyst fluid analysis, for an additional 42 cases. This provided us with 127 total cases.

Purpose: Pain is the hallmark symptom of chronic pancreatitis (CP) and the main reason for physician visits and hospitalizations. We thus tested the hypothesis that pain severity correlates with resource utilization (RU).

Methods: Records of patients with established pancreatitis seen at least twice between 4/2008 and 12/2009 at the University of Pittsburgh Digestive Disorder Clinic were retrospectively reviewed.

Results: During 123 patient-years of follow up in 116 patients, we recorded 187 emergency room visits (n = 46 patients), 140 hospitalizations (n = 51 patients) amounting to a total of 774 inpatients treatment days. 10 patients accounted for 51% of the inpatient days and only 5 patients were responsible for 54% of the emergency room visits. Neither subjective pain ratings nor the average daily opioid use differed between high and low resource users. However, significantly more patients with higher RU had alcoholic pancreatitis (n = 7; χ2 = 4.82, P<0.05). Imaging studies of the pancreas were obtained in 97 of these 116 patients (235 CT, 28 MRCP, 37 abdominal ultrasound examinations, 20 endoscopic ultrasound examinations and 70 ERCP). Thirteen patients were responsible for 40.67% of the CT scans (figure 1). The cumulative exposure diagnostic radiation was 23.3±3.0 mSv with 33 (28%) patients exceeding annual ­exposures

[124] K-Ras gene mutation status and relationship to other clinical data Cytology NA*

NonDiagnostic

Mucin

CEA (ng/ml)

Surgical Pathology

Malignancy

NA

> 192

< 192

NA

Benign†

PreMalignant††

Demographics Malignant†††

Age (average)

Male

Female

K-Ras Gene Mutation NA

17

19

21

6

65

11

11

40

13

22

12

58.6

34

53

NonDiagnostic

1

0

0

0

1

0

0

1

0

0

0

57

0

1

Negative

0

14

0

0

5

2

14

19

0

2

0

51.4

11

10

Positive

0

6

7

2

7

4

7

15

0

3

0

66.6

8

10

Total

18

39

28

8

78

17

32

75

13

27

12

53

74

*NA - Not Available †Benign - benign cyst (1), chronic pancreatitis (1), abscess (1), pseudotumor (1), pseudocyst (2), non-pathologic (1), lymphoepithelial cyst (1), lymphangiectatic cyst (1), serous cystadenoma (4) ††Pre-Malignant - pseudopapillary tumor (1), pancreatic intraepithelial neoplasia (PanIN) (1), serous cystadenoma and PanIN (2), mucinous cystadenoma (2), mucinous cystadenoma with dysplasia (1), mucinous cystadenoma and PanIN(1), IPMN (7), IPMN with dysplasia (12) †††Malignant - neuroendocrine tumor (5), adenocarcinoma (5), mucinous carcinoma (2).

The American Journal of Gastroenterology

Volume 106 | supplement 2

| October 2011

www.amjgastro.com

Abstracts

of 20 mSv. The use of diagnostic testing was primarily influenced by diseasespecific variables (etiology, disease duration and complications) with the presence of pseudocysts being the best predictor of CT use, accounting for 11% of the variance. Twenty-two patients had a total of 23 surgeries, 19 of which targeted the pancreas with resections (n = 15) or drainage operations (n = 4).

Conclusion: Patients with CP frequently require emergency care and hospitalization with a small subgroup being responsible for about half of the consumed resources. The high fraction of patients with alcoholic CP in this group suggests an important contribution of psychiatric factors, which should be considered in designing comprehensive approaches to effectively manage these patients.

Histogram showing the distribution of surrogate markers for resource utilization i.e. CT scans.

126 Necessity of a Repeat Cholangiogram During Biliary Stent Removal after Post-cholecystectomy Bile Leak?

Vishal Jain, MD, Beshir Hiba, MD, Nake Pooran, MD. PennState Hershey Medical Center, Hershey, PA. Purpose: To assess the need for repeat ERC (endoscopic retrograde cholangiography) in patients with biliary stent placed for post-cholecystectomy bile leak.

Methods: A retrospective analysis of the CORI (Clinical Outcomes Research Initiative) database at Penn State Milton S Hershey Medical Center identified all patients referred for ERC for post-cholecystectomy bile leak from Jan 2001June 2010. We collected baseline demographics, location of bile leak, size of biliary stent placed, duration of stenting, bile leak persistence, and the presence of stone, sludge or strictures on repeat ERC. Results: Total of 81 patients underwent ERC for management of bile leaks after cholecystectomy. One was excluded as he had a complete transection of the CBD and taken to the OR immediately. Fourteen (17.5%) patients had open cholecystectomy, 46 (57.5%) had laparoscopic and 10 (12.5%) had a laparoscopic converted to open. Of the 80 patients, 47 (58.7 %) had a Cystic duct leak, 11 (13.7 %) had a Right hepatic duct leak, 11 (13.7%) had CBD leak, 5 (6.2%) had a GB fossa leak, 4 (5%) had CHD leak and the other 2 (2.5%) had Left Hepatic duct leak. All 80 patients (100%) had a biliary stent placed. 57 of 80 (71.2%) had a 10F stent placed with the remainder having a 7F placed. Seventy-five (93.7 %) patients also underwent biliary sphincterotomy at the same time. Sixty-nine patients (11 had no repeat cholangiogram but clinically the leak had resolved) underwent repeat ERC after a mean duration of 8.2 weeks.

Three had an early ERC due to suspicion for cholangitis and hence excluded from the analysis. Of the 66 included in the final analysis, 61 (92.4 %) had resolution of the bile leak on repeat ERC. All patients had a resolution of their bile leak by the third ERC. Fifteen patients (22.7 %) had an abnormality on repeat cholangiography (persistent leak in 4, stones in 3, sludge in 7, and leak + stone in 1) that required further intervention including balloon sweep, or further stenting.

© 2011 by the American College of Gastroenterology

Conclusion: Although the majority of post cholecystectomy bile leaks resolve after biliary stent placement, a sizeable percentage of patients still have abnormalities on the subsequent cholangiogram that requires further endotherapy.

These findings support the need for a repeat ERC +/- of balloon sweep at the time of biliary stent removal.

127 Implication on Bariatric Surgery by Disregarded Neural Related Structures in the Hepato-Bilio-Pancreas-Gastro-Intestinal Tract in the Rat Osvaldo Tiscornia, Chief “Programa Estudios Pancreáticos”, Full Professor and Chair, Department of Anatomy, Universidad Catolica Argentina, FACG,3 Gustavo Negri, PhD, Full Professor and Chair, Department of Bioquímica Clínica, Facultad de Farmacia y Bioquímica, INFIBIOC, UBA,4 Susana Hamamura, MD, médico “Programa Estudios Pancreáticos”, servicio gastroenterología,1 Graciela Otero, PhD, Citotécnica “Programa Estudios Pancreáticos”,1 Hipolito Waisman, MD, médico “Programa Estudios Pancreáticos”, servicio cirugía,1 María Maselli, PhD, Bioquímica, Departamento de Bioquímica Clínica, Facultad de Farmacia y Bioquímica, INFIBIOC, UBA,4 Fabiana López Mingorance, PhD, Bioquímica “Programa Estudios Pancreáticos”, ayudante1°-Departamento de Bioquímica Clínica, Facultad de Farmacia y Bioquímica, INFIBIOC, UBA,1 Patricia TiscorniaWasserman, Chief, Division of Cytopathology, North Shore-Long Island Jewish Departmnet of Pathology and Laboratory Medicine2. 1. Programa de Estudios Pancreáticos, Hospital de Clínicas, UBA, Buenos Aires, Argentina; 2. North Shore - LIJ Hopital, New York, NY; 3. Universidad Católica Argetina, Buenos Aires, Argentina; 4. Lab de Gastroenterología y Enzimología Clínica, Departamento de Bioquímica Clínica, Facultad de Farmacia y Bioquímica, INFIBIOC, UBA, Buenos Aires, Argentina.

Purpose: The aim of this report is to describe essentially macroscopic anatomical findings; secondarily, some microscopic details, of an evaluation carried out in 300 Wistar rats. This approach was restricted primarily to the neural autonomic innervation of the hepato-bilio-pancreato-gastro-intestinal tract.

Methods: In male animals, body weight 150 to 600 g, under eter or tiopental anesthesia, with delicate instruments and the support of a dissecting microscope (Wild), a microscopic analysis (linear neuronal counting) of the submucous and the myenteric ganglionated plexus was performed, respectively, in the duodenal and the stomach antral segment.

Results: Table 1. Emphasis was put on several structures, unexpectedly disregarded in the literature, like, e.g, the diagonal antral band (DAB), a connective nervous band extended from the antral-fundic-junction(AFJ) up to the pylorus; the pre-bile duct-nodular-plexus(PBDNP); the neural fibers that jump the duodeno-pancreatic-cleft-plexus (DPCP), first described in the literature by our group in the sixties; the peri-Vaterian-Center (PVC), with its rich neural density, considered a real autonomic -neural-brain (ANB), and a main starting trigger of autonomic-arc-reflexes, primarily upon the pancreatic “revolver”, pivotal background of a model to mimick human biliary acute pancreatitis; the peculiar arrangement of the celiac ganglia and their linking with the PVC through the perivascular neural network of the inferior pancreatico-duodenal-artery(IPDA). In the PVC and the AFJ a greater linear neuronal counting, respectively, of the submucous and myenteric ganglia when compared with their adjacent zones.

Conclusion: The section and reanastomosis at the level of the AFJ is an inducer of antral peptic ulcers that mimick the human one. The PBDNP and the DAB constitute a “carrrefour” of nerve fibers coming from different sources. Neural impulses, either sympathetic and/or peptidergic, starting from them, the same as those originated from th or the DPCP, modulate, at the level of the neural plexuses of the biliary tract and the hepatic gland, their autonomic neural tone background. The surgical interruption of this modulation, e.g, through a “cicatricial barrier” in what we have called the enteric neural plexus freeway (ENPF), induce trophic changes of the pancreatic gland, and, through an enhancement of the hepatic cholinergic tone an increased release of the Lautt postulated factor (hepatic-insulin-sensitizing-substance, HISS) and, consequently, an improved response of the insulin receptors primarily in the skeletal muscle. The latter, if confirmed in humans, might undoubtedly constitute a much simpler and less dangerous approach to the treatment of morbid obesity in the field of bariatric surgery.

The American Journal of Gastroenterology

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S52

Abstracts

[127] Table 1. Oral glucose tolerance test- cumulative value 60 min Gly mg% Control Sham

PV-SRA

413±22

− 12%

NS

469±22 n=7

PV-DPD

432±32

− 8%

NS

ADPD

394±21

− 16%

P < 0.05

Ins µU/ml Control Sham

PV-SRA

367±12

− 36%

P < 0.025

569±71 n=7

PV-DPD

250±15

− 56%

P < 0.05

333±10

− 42%

P < 0.025

ADPD

HOMA IR Control Sham

PV-SRA

35±1

− 36%

P < 0.05

55±8 n=7

PV-DPD

22±6

− 60%

P < 0.001

ADPD

42±13

− 42%

NS

PV-SRA peri-Vaterian section-reanastomosis duodenal wall PV-DPD peri-Vaterian duodeno-pancreas neural disconnection ADPD gastric antrum duodeno pancreas neural disconnection.

128 Peri-Vaterian Duodenal Irritation: Main Physiopathogenic Mechanism of Biliary Acute Pancreatitis. Its Mimicking by the “Short-Term” (<20 min) “Closed Duodenal-Loop” The Beneficial Role of Topical Anesthesia of the Trigger Zone Osvaldo Tiscornia, Chief “Programa Estudios Pancreáticos”, Full Professor and Chair, Department of Anatomy, Universidad Catolica Argentina, FACG,1 Gustavo Negri, Full Professor and Chair, Department of Bioquímica Clínica, Facultad de Farmacia y Bioquímica, INFIBIOC, UBA,4 Susana Hamamura, MD, medico “Programa Estudios Pancreáticos”, servicio gastroenterología,2 Graciela Otero, PhD, Citotecnica “Programa Estudios Pancreáticos”,2 Hipolito Waisman, MD, medico “Programa Estudios Pancreáticos”, servicio cirugía,2 Fabiana López Mingorance, PhD, Bioquímica “Programa Estudios Pancreáticos”, ayudante1-Departamento de Bioquímica Clínica, Facultad de Farmacia y Bioquímica, INFIBIOC, UBA,2 Patricia Tiscornia-Wasserman, Chief, Division of Cytopathology, North Shore-Long Island Jewish Department of Pathology and Laboratory Medicine3. 1. Universidad Católica Argetina, Buenos Aires, Argentina; 2. Programa de Estudios Pancreáticos, Hospital de Clínicas, UBA, Buenos Aires, Argentina; 3. North Shore - LIJ Hospital, New York, NY; 4. Lab de Gastroenterología y Enzimología Clínica, Departamento de Bioquímica Clínica, Facultad de Farmacia y Bioquímica, INFIBIOC, UBA, Buenos Aires, Argentina.

Purpose: We have shown in humans, dogs, opossum and rats that the periVaterian Duodenum (PVD)is the starting point of activation of autonomic arc reflexes(AAR). Three complex nervous systems are involved: the vagal, the splanchnic-celiac, the entero-pancreatic and the sensory afferent. Three types ofAAR are elicited: the secretory inhibitor, the sympatho-ischemic(ischemia through opening of arterio-venous shunts), the pseudo-axonic(neurogenic inflammation). The irritation of the afferent, nerve fibers by stones or blood clots in the bile duct outlet; surgical or intemperate maneuvers in the PVD,is the pivotal mechanism of biliary acute pancreatitis(BAP). The aim of this report is to describe our experimental approach to mimick, through a surgical model this frequent entity.

Methods: 73 male Wistar rats were studied. Under ip tiopental anesthesia, the left jugular vein was catheterized. Amylasemia, lipasemia and WBC was determined. Through a catheter inserted in the gastric antrum, a duodenal loop,comprised between a ligature at the pylorus and another placed below the bile-pancreatic duct outlet, was filled with sodium taurocholate stained with blue methylene. This allowed to check, de visu, whether or not reflux occurred in the bile duct. This is never observed below a 20’lapse. When occationaly observed, the test was interrupted.In 1° series,n = 21, the changes were evaluated at2h,when a complete autopsy is performed. In the2°series n = 11,the same protocol was performed at 24h. The results were compared with those of a shamgroup,n = 25. In the 1rst series, two subgroups were considered, one control(C)n = 11 and another experimental(E)n = 10, in which lidocaine was The American Journal of Gastroenterology

instilled into the duodenum previous to the duodenal loop construction.

Results: In both the 1°and 2° experimental series, it was microscopic remarkable that the pancreatic ductal tree was free of any extraneous luminal content with an absence of any kind of damage of both bile and pancreatic duct epithelium. This fact coupled to the spotty distribution of the acute pancreatitis lesions gives strong support to our contention that the inflammatory lesions are induced independently of any duodenal content in the bile-pancreatic ducts. These findings do not favor the Opie physiopathogenic mechanism of BAP; in contrast, they provide added support to our hypothesis that the pivotal axis of this entity is centered in the irritation and consequent over activation of the AAR. Conclusion: The fact that topical anesthesia of the PVD, the most sensitive zone of the duodenum, induce a lower leucocyte count,a reduced level of amylasemia and lipasemia, is another suggestive feature that is coherent with our hypothesis of BAPhere delineated.

129 “Pancreatogram:” A Non-invasive Test that Allows an Encompassing View of the Exocrine-endocrine Pancreas Interaction Osvaldo Tiscornia, Chief “Programa Estudios Pancreáticos”, Full Professor and Chair, Department of Anatomy, Universidad Catolica Argentina, FACG,2 Gustavo Negri, PhD, Full Professor and Chair, Department of Bioquímica Clínica, Facultad de Farmacia y Bioquímica, INFIBIOC, UBA,3 Susana Hamamura, MD, medico “Programa Estudios Pancreáticos”, servicio gastroenterologÃa,1 Graciela Otero, PhD, Citotecnica “Programa Estudios Pancreáticos”,1 Hipolito Waisman, MD, medico “Programa Estudios Pancreáticos”, servicio cirugía,1 María Maselli, PhD, Bioquímica, Departamento de Bioquímica Clínica, Facultad de Farmacia y Bioquímica, INFIBIOC, UBA,3 Fabiana López Mingorance, PhD, Bioquímica “Programa Estudios Pancreáticos”, Departamento de Bioquímica Clínica, Facultad de Farmacia y Bioquímica, INFIBIOC, UBA,1 Patricia Tiscornia-Wasserman, Chief, Division of Cytopathology, North Shore-Long Island Jewish Departmentt of Pathology and Laboratory Medicine4. 1. Hospital de Clínicas, Programa de Estudios Pancreáticos, Buenos Aires, Argentina; 2. Universidad Católica Argentina, Buenos Aires, Argentina; 3. Lab de Gastroenterología y Enzimología Clínica, Departamento de Bioquímica Clínica, Facultad de Farmacia y Bioquímica, INFIBIOC, UBA, Buenos Aires, Argentina; 4. North Shore - LIJ Hospital, New York, NY. Purpose: The literature and our own research has put in evidence that between the two bullets in the barrell of the pancreatic revolver, the Langerhan islets and the pancreon units, evolve a subtle and significant interplay which revealed to be altered in glucose intolerant and diabetic patients. This type of approach, centered in the classical oral glucose tolerance test, gets an evident enhanced diagnostic value when to the measurement of glucose and insulin the blood values of the pancreon enzymes, such as amylase, pancreatic isoamylase, lipase and also calcium are added to each sample of the 2-hr test. A compeller feature that induced to pursue in this line of study was that a preliminary analysis confirmed that its information kept an undoubted coherence with the patient’s clinical history and the collateral laboratory and imaging studies. The aim of this report is to put into consideration an outline of our findings in a control (C)group and in patients classified either as intolerant(I) or diabetics(D).

Methods: Patients of both sexes 31-75 years of age, divided in three groups: C(n = 38); I (n = 32) and D(n = 19). Following a 12 hr fasting period, and after taking a venous blood sample,75 g of glucose dissolved in 375 ml of water was orally administered. Post ingestion venous samples,at 30, 60, 120 min were taken. Glycemia, amylasemia, pancreatic isoamylasemia, lipasemia and calcium were determined. The main emphasis was put in the cumulative value(C. V)(basal+30+60+120min) of each parameter. With the C.V, diagnostic indexes (D.I), resulting of the correlation of glycemia with the different exocrine enzymes and calcium,is also put into consideration. As it was considered suitable, either the ANOVA or a non-parametric test (Kruskal-Wallis) was also applied.

Results: Tables N = 1 and 2.

Conclusion: The analysis of the Tables reveal quite evidently that centering the results evaluation in the C.Vof each parameter clearly trigger a distinctive delineation of the insulo-pancreon-axis interaction. This makes easier the insertion of the patient in the appropiate group. Another undoubted improvement Volume 106 | supplement 2

| October 2011

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Abstracts

is that provided by the D.I. Appealing to all of them makes notoriously easier differentiate the C from the I group. There is no doubt that through a sequential testing of our here proposed Pancreatogram one is surely able to accurately establish if the patient under scrutiny keeps a stable functional insulo pancreon-axis condition, or, otherwise, is showing signs of either progressive deterioration or stimulating improvement.

Table 1. Diagnostic indexes C

I

D

CvsI

CvsD

IvsD

X±DS

X±DS

X±DS

P

P

P

P

Glu/Ins

3.5±1.7

3.6±1.7

10.9±7.9

< 0.0001

ns

Glu/Ami

1.4±0.8

2.6±1.2

4.8±1.7

< 0.0001

< 0.001

< 0.001

< 0.01

Glu/Lip

1.8±1.3

3.0±1.4

3.2±1.8

< 0.0001

< 0.001

< 0.01

ns

Glu/Ca

12.4±2.3

18.6±3.5

29.6±7.2

< 0.0001

< 0.001

< 0.001 < 0.001

< 0.001 < 0.001

Table 2. 2hs Cumulative value C

I

D

CvsI

CvsD

IvsD

X±DS

X±DS

X±DS

P

P

P

P

Glu (mg/dl)

471±71

630±77

869±138

< 0.001

< 0.001

< 0.001

< 0.001

Ami (UI/l)

386±173

297±125

228±95

< 0.003

< 0.05

< 0.001

ns

Lip (UI/l)

344±184

268±128

379±192

< 0.04

ns

ns

ns

Ca (mg/dl)

34.9±6.7

35.9±5.3

33.9±4.9

ns

ns

ns

ns

Ins (µU/l)

144±55

242±165

173±141

< 0.0004

< 0.001

ns

ns

130 Biliary Cannulation by Precut Papillotomy to the Inaccessible Intradiverticular Papilla. Method Used in the Mederi - Major University Hospital, Reference Center for ERCP from Bogota Diana Torres, Internal Medicine, Gastroenterology, Samuel Rey, Surgeon, Gastroenterology, German Junca, Surgeon, Gastroenterology. Hospital Universitario Mayor Mederi, Bogota, Colombia.

Purpose: Presenting an alternative method for intradiverticular papilla cannulation. Success rates and complications in Mederi University Hospital, a referral center for ERCP in Bogota, Colombia are shown. Since introduction of endoscopic cannulations of the ampulla of Vater, endoscopic retrograde cholangiopancreatography has become a widely used procedure for evaluating suspected biliary tract and pancreatic disease. ERCP is kind of sophisticated technique that can be successfully mastered by the trained endoscopist after a reasonable time commitment and good training. However, the ampulla that sits inside the duodenal diverticulum may be the cause of a difficult biliary access, due to the awkward angle of the opening, especially the one that faces laterally or backward. Many techniques have been recommended to encounter this problem.

Some experts suggest, among others, the placement of a pancreatic stent to keep the papilla out of the diverticulum, or a sub mucosa injection to evert the papilla, or the placing of clips. It is an observational case during a period of 21 months of a series of patients, admitted to our hospital with a diagnosis of choledocholithiasis for biliary therapeutic endoscopic intervention. 719 patients (372 women, 347 men) were admitted. Of those, 32 intradiverticular papillae were found (18 women, 14 men) so we proceeded to papilla cannulation with precut papillotomy. The success rate of cannulations was 100% (32/32) with precut papillotomy. Only in 21 of 33 (63%) patients stone extraction was performed. In the remainder, we placed biliary stent until resolve lithiasis with surgery. There were no complications, but the procedure was lengthen, lasting 30 to 45 minutes. It is concluded that the practice of precut papillotomy can be effective and safe when is performed by expert endoscopist of biliary intervention. Even in patients who have papilla intradiverticular location It allows access to the bile duct to remove stones or insert biliary stents. © 2011 by the American College of Gastroenterology

131 No Effect of Drugs Reducing Gastric Acid Production on the Efficacy of Pancrelipase Delayed-Release Capsules (CREON®) in Randomized Trials of Patients with Exocrine Pancreatic Insufficiency Paul Pollack, MD,1 Suntje Sander-Struckmeier, PhD,2 Katrin Beckmann, MS,2 Gwendolyn Janssen-van Solingen, MSc3. 1. Abbott, Chicago, IL; 2. Abbott, Hannover, Germany; 3. Abbott, Allschwil, Switzerland.

Purpose: In patients with exocrine pancreatic insufficiency (EPI), proton pump inhibitors (PPIs) or histamine-2 receptor antagonists (H2RAs) are sometimes given with pancreatic enzyme replacement therapy (PERT) for gastric or duodenal hyperacidity, which may influence the timing of enzyme release. Concomitant use of PPIs/H2RAs with pancrelipase delayed-release capsules (CREON®,) is not routinely required or recommended; it may be recommended if there is continued inadequate response after a dose increase. The purpose of this analysis was to determine whether concomitant use of PPIs/ H2RAs may affect pancrelipase (CREON®) efficacy.

Methods: This was a subanalysis of combined data from three doubleblind, randomized, multicenter, placebo-controlled trials of pancrelipase (CREON®; trials 3.124 [NCT00414908], 4.009 [NCT00705978], and 3.126 [NCT00510484]). Trials 3.124 and 4.009 were parallel-group trials enrolling patients ≥18 years old with confirmed EPI due to chronic pancreatitis (CP) or pancreatic surgery (PS; trial 3.124 only). After a run-in period without PERT, patients were randomized to pancrelipase or placebo for 7 days. Trial 3.126 was a cross-over study in patients ≥12 years old with EPI due to cystic fibrosis (CF) who were randomized to pancrelipase then placebo, or placebo then pancrelipase, for 5 days each with a 3-14 day intervening washout on patients’ usual PERT. In all studies: patients received a diet providing ≥100 g fat/day; patients already taking PPIs/H2RAs could continue them at a stable dose; the primary endpoint was the coefficient of fat absorption (CFA). Prospectively planned exploratory analysis of CFA outcomes according to PPI/H2RA use versus no use was carried out in each study (statistical comparisons not performed). No subjects took H2RAs in trial 4.009.

Results: There were no meaningful differences in CFA values on pancrelipase at the end of the treatment period according to PPI/H2RA use (Table). In all three studies, the mean CFA was >85% in both subgroups.

Conclusion: In three double-blind, randomized, placebo-controlled trials enrolling patients with EPI due to CP, PS, or CF, there were no differences in pancrelipase (CREON®) efficacy related to PPI/H2RA use, as determined by CFA values on pancrelipase. Supported by Abbott, Marietta, GA. Disclosure: P Pollack - Employee: Abbott; S Sander-Struckmeier - Employee: Abbott; K Beckmann - Employee: Abbott; G Janssen-van Solingen - Employee: Abbott.

This research was supported by an industry grant from Abbott.

Mean CFA on pancrelipase at end of double-blind phase PPI/H2RA use Study

Population

N

Dose, lipase units

3.124

CP/PS

54

4.009

CP

62

3.126

CF

32

No PPI/H2RA use

n

CFA (%)

n

CFA (%)

72,000/meal

9

87.0

13

85.7

80,000/meal

12

86.2

20

86.0

Mean 4,189/g fat intake

18

88.5

13

88.8

132 Malignant Biliary Obstruction Increases Significantly Serum Lipid Levels: A Novel Biochemical Tumor Marker?

Mustafa Kaplan, Internal Medicine Specialist,1 Yusuf Yazgan, Assistant Professor,1 Kemal Oncu, Associate Professor,1 Alpaslan Tanoglu, Internal Medicine Specialist,1 Mustafa Dinc, Internal Medicine Specialist,2 Irfan Kucuk, Internal Medicine Specialist,1 Levent Demirturk, Professor1. 1. GATA Haydarpasa Training Hospital,Gastroenterology Department, Istanbul, Turkey; 2. GATA Haydarpasa Training Hospital, Internal Medicine Department, Istanbul, Turkey.

Purpose: We aimed to investigate the alterations in serum lipid levels due to biliary obstruction associated with benign and malignant cases. Also we aimed The American Journal of Gastroenterology

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to examine the possibility of the theory that extremely high serum lipid levels can predict the malignant biliary obstruction in the differantial diagnosis.

Methods: Four hundred fifty patients who were performed endoscopic retrograde cholangiopancreatography with the intrahepatic and extra­hepatic cholestasis were reviewed in the period from September 2007 to October 2010.

Results: In the malignant obstruction group, meaningfully higher total cholesterol (p< 0,001), low-density lipoprotein (p>0,05) and triglycerides (p<0,05) were observed, but high-density lipoprotein (p<0,05) levels were lower. The receiver operating characteristic analysis showed that total cholesterol 246,74 mg/dl or less (sensitivity:84,3%, spesificity:83,3% area under the curve: 0,705 (0,620-0,790), (p <0,001) and high-density lipoprotein cholesterol area under the curve: 0,577 (0,444-0,710) were predictors of malignant biliary obstruction.

Conclusion: Serum lipid profile may be used as an applicant marker to identify malignant reasons of the obstructive jaundice.

133 Aprepitant, a Neurokinin-1 Receptor Antagonist, for Prevention of PostERCP Pancreatitis in High Risk Patients: A Randomized, Double-blind, Placebo Controlled Trial Tilak Shah, MD, Martin Poleski, MD, CM, M. Stanley Branch, MD, Paul Jowell, MBChB, Jorge Obando, MD, Rodger Liddle, MD. Gastroenterology, Duke University Medical Center, Durham, NC. Purpose: Post-ERCP pancreatitis can occur in up to 40% of high risk patients.

Animal studies have demonstrated a role for substance P binding to neurokinin-1 receptor in the pathogenesis of acute pancreatitis. Our aim was to determine the efficacy of a neurokinin-1 receptor antagonist (aprepitant) to prevent post-ERCP pancreatitis in high risk patients.

Methods: High risk adult patients (suspected sphincter of Oddi dysfunction, prior post-ERCP pancreatitis, expected sphincterotomy, and age<60 years) were randomized in a double-blind fashion to receive either 125 mg oral aprepitant or placebo 4 hours prior to ERCP, 80 mg 24 hours after the first dose, and then 80 mg 24 hours after the second dose. Patients were contacted at 48 hours and 7 days post-procedure. Imaging and laboratory studies were collected for all patients who sought medical attention. Chi-square test was used to compare incidence of post-ERCP pancreatitis between the two groups, defined as new onset or increased abdominal pain requiring admission that was associated with amylase or lipase >3 times upper limit of normal.

Results: 34 patients were randomized to receive aprepitant and 39 patients received placebo. Baseline characteristics were similar between the two groups (Table 1). Incidence of acute pancreatitis was 7 in the aprepitant group and 7 in the placebo group (p = 0.77). 5 and 9 patients required hospitalization for abdominal pain that did not meet criteria for acute pancreatitis within 7 days post-procedure in the aprepitant and placebo groups respectively (p = 0.54).

Mean age was 37 years among all patients who developed pancreatitis and 50

Table 1. Baseline characteristics of patients who received Aprepitant vs. placebo Placebo (n=39)

Aprepitant (n=34)

P-value

Female

30

25

0.74

Mean Age

46

50

0.24

Current Alcohol use

8

9

0.55

Sphincter of Oddi Manometry

8

4

0.31

Pancreatic stent

24

22

0.78

Pancreatic sphincterotomy

10

16

0.057

Biliary stent

6

3

0.4

Biliary sphincterotomy

16

5

0.79

The American Journal of Gastroenterology

years among all patients who did not develop pancreatitis (p = 0.0027). Insertion of a pancreatic stent was not associated with a lower incidence of acute pancreatitis (p = 0.91).

Conclusion: Aprepitant did not lower incidence of post-ERCP pancreatitis in this study, but findings are limited by small sample size. Larger studies potentially using the recently available intravenous formulation are necessary to determine efficacy of aprepitant in this setting (we estimate a sample size of about 250 is necessary to detect difference in primary outcome with α = 0.05 and β = 0.2).

This research was supported by an industry grant from Merck.

134 A Simple Method for Determining the Etiology and Treatment of Idiopathic Acute Pancreatitis Aigul Guilmanova, MD, Ekaterina Sikorskaya, MD, Dennis Marino, BS, Dennis Khodasevich, BA, Robin Baradarian, MD, FACG, Scott Tenner, MD, MPH, FACG. State University of New York, Brooklyn, NY. Purpose: Idiopathic Acute Pancreatitis is best defined by the presence of acute pancreatitis in the absence of gallstones, history of alcoholism, hypertriglyceridemia and tumors. There are many possible other causes of acute pancreatitis which must be entertained in such patients, including biliary sludge (microlithiasis), sphincter of Oddi dysfunction, pancreas divism, drugs, etc. However, it has been recognized that a passed common bile duct stone, even in the absence of other stones or sludge in the gallbladder and with normal transaminases, may be the most common cause. With this suspicion, and realizing that the development of a single common bile duct stone in any particular patient will likely lead to other stones in the future, the following study was performed: Methods: A consecutive series of patients with idiopathic acute pancreatitis as defined above were studied. All patients had undergone an MRCP. Patients were excluded if there was any evidence of chronic pancreatitis, tumors, pancreas divisim or biliary sludge. Patients were followed for the development of acute pancreatitis. Transabdominal ultrasound (US) was performed at 3 month intervals. If gallstones or biliary sludge was identified on transabdominal ultrasound, cholecystectomy was performed.

Results: Twenty-four consecutive patients, 15 female, 9 male, median age 54 year (23 - 78) with idiopathic pancreatitis were studied. All patients had at least one episode of acute pancreatitis with no obvious etiology as defined above.

16 patients had one episode of acute pancreatitis, 8 patients had at least 2 episodes of acute pancreatitis. Baseline transabdominal ultrasound was normal (no gallstones or sludge) in all patients. With a median follow-up of 33 months (range 7 - 101), 7 patients developed gallstones and 9 patients developed biliary sludge on ultrasound. In these 16/24 patients with idiopathic pancreatitis who had developed either gallstones or biliary sludge, a cholecystectomy was performed in 14/16 patients. There were no complications to cholecystectomy.

During the follow-up period, only 1 patient developed another episode of acute pancreatitis. Interestingly, this patient had elevated transaminases suggestive of a common bile duct stone.

Conclusion: In patients with idiopathic acute pancreatitis, serial transabdominal ultrasound at 3 month intervals will, over time, identify a significant number of patients with biliary sludge and/or gallstones. Cholecystectomy in these patients may help prevent recurrent episodes of acute pancreatitis. Further study is needed to verify the efficacy of this approach in the diagnosis and treatment of acute idiopathic pancreatitis.

135 Prevalence of Diabetes Mellitus in Common Cancers Gaurav Aggarwal, MD,1 Pratima Kamada, MD,2 Suresh Chari, MD1.

1. Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, Rochester, MN; 2. Brackenridge Medical Center, Austin, TX. Purpose: While long standing DM is a risk factor for pancreatic cancer, new-onset DM (onset in the 36 months preceding cancer diagnosis) is a Volume 106 | supplement 2

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harbinger of the disease. However, DM is an established risk factor for other malignancies as well. The aim of this study was to compare the prevalence and characteristics of DM in the 4 most common malignancies in the United States (lung, breast, prostate, colorectal) with pancreatic cancer and non-cancer controls.

Methods: Medical records of 500 cancer patients, 100 each diagnosed with lung cancer, breast cancer, prostate cancer, colorectal cancer or pancreatic cancer and 100 non-cancer controls, seen at Mayo Clinic, Rochester in 2007 were reviewed retrospectively. A fasting blood glucose value of ≥ 126 mg/dL, physician diagnosis of DM in the chart or use of anti-diabetic medications were used to define DM status. For cases and controls without known DM, the most recent blood glucose measurement in the 12 months preceding the index date was noted. Data on duration of DM was also abstracted.

Results: Patients with PaC (71.6±9.4 years; 53 male) had a significantly (p<0.0001) higher prevalence (68%) of DM compared to age-matched patients with lung cancer (71.6±9.4 years, 59 male, 19.6%), breast cancer (71.6±9.6 years, 19.4%), prostate cancer (71.3±9.4 years, 14.8%), colorectal cancer (71.6±9.5 years, 56 male, 20.7%), and controls (70.7±9.2 years, 57 male, 23.5%), despite similar BMI and family history of DM (p>0.05) when PaC patients were compared to the other groups. There was no difference in the prevalence of DM among non-PaC cancer patients and controls (p = 0.49). Among the patients with PaC, 40% developed DM in the 36 months preceding the diagnosis of cancer, as compared to patients with other cancers and non-cancer controls where this proportion ranged from 3.3-5.7% (p<0.0001).

Conclusion: While DM is often found in patients with cancer, patients with PaC have a significantly higher prevalence of DM than other cancers.

In particular, new-onset DM is a phenomenon that is unique to PaC.

[136] Table 2. Surgical outcomes (%) Pylorus Preserving Whipple

68

Distal Pancreatectomy

28

Total Pancreatectomy

1

End-To-Side Choledochoduodenostomy

1

Roux-en-Y Pancreaticojejunostomy

1

Nonsurgical (metastatic upon presentation)

3

Case 1 with duodenal bulb fistulization seen here on ERCP image. This patient was managed with definitive surgical bypass and is doing well one year later.

136 Biliary Fistulization Complicating Intraductal Papillary Mucinous Neoplasm Robin Atkinson, DO, Michael Gluck, MD. Virginia Mason Medical Center, Seattle, WA. Purpose: Intraductal papillary mucinous neoplasms (IPMN) are exocrine cystic neoplasms of the pancreas with 30-40% potential for malignant transformation over 15-20 years. The location may be main duct, side branch or both.

Spontaneous biliary fistulization occurs rarely but presents a difficult management dilemma.

Methods: This is a retrospective chart review of patients with IPMN identified by ICD-9-CM code and pathology specimens from January 1, 2000 to September 30, 2010 at a tertiary pancreatic medical facility. IRB 10071 approved.

Results: 154 patients with IPMN who underwent surgery or were biopsy proven (Table 2). Overall mean age was 67 years with sixty percent female.

Presenting symptoms included abdominal pain (43%), pancreatitis (18%), weight loss (7%), and jaundice (6%). Nineteen percent were asymptomatic. Of the six percent with jaundice, two patients (1.3%) presented with spontaneous biliary fistulization. Patient 1 underwent three ERCPs for stent exchange in addition to ten percutaneous transheptic biliary drains prior to definitive

Table 1. IPMN distribution upon presentation (%) Cystic Mass Head

55

Body

13

Tail

10

Mixed

6

Ductal Dilation

14

Papillary Mass

1

© 2011 by the American College of Gastroenterology

pylorus-preserving pancreaticoduodenectomy. Patient 2 underwent fourteen ERCPs over two years before undergoing palliative end-to-side choledochoduodenostomy.

Conclusion: In this tertiary pancreatic cancer referral center, 1.3% of treated patients with IPMN presented with spontaneous biliary fistulization that could not be managed endoscopically or percutaneously. Surgical biliary bypass appears required in this setting.

137 Vitamin D’s Role in Pathogenesis of Thromboembolism. Is This an Epiphenomenon?

Ali Abbas, MBBS,1 Alan Hutson, PhD,2 Alok Khorana, MD,3 Renuka Iyer, MD2.

1. University at Buffalo, Buffalo, NY; 2. Roswell Park Cancer Institute, Buffalo, NY; 3. University of Rochester, Rochester, NY. Purpose: Pancreatic and biliary cancers (PBC) have high risk of thromboembolism (TE) with significant morbidity as well as mortality. Studies have suggested that vitamin D down regulates tissue factor (TF) expression. In vitamin D receptor knockout mice high levels of tissue factor gene expression was present. Therefore, we hypothesized vitamin D levels in patients with PBC may have inverse correlation with TF level and TE. Methods: With IRB approval, demographic, treatment and clinical outcome related information was obtained on all patients with PBC diagnosed between 1/2005 to 12/2008 with available clinical data and plasma in our institute’s biorepository. The vitamin D and TF micro particle level was measured in de-identified samples using previously established assays. The clinical data collected independently was merged with vitamin D and TF level for analysis.

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Results: The study included 117 patients. Demographics: M/F 52/65; Race: Caucasian 108, AA 7, Other 2; Median age 65 yrs(40-85); Tumor: Pancreas 80, Biliary 34, Unknown primary 3. TE occurred in 52(44.4%) patients [PE 15, DVT 21, and Others 29]. Mean and Median TF for all patients was 2.15 and 1.20 pg/ml, range 0.17-31.01 and vitamin D for all patients was 50.1 and 46.83 ng/ml, range 3.08-60.71 ng/ml. Elevated TF was significantly associated with TE in logistic regression analysis (OR = 1.22, p = 0.04). There was no correlation between vitamin D level and TF (r = -0.03, p = 0.76) and vitamin D and TE (OR = 0.997,p = 0.88).

Conclusion: Although the range of vitamin D levels was consistent with those reported in cancer patients, no correlation was seen with tissue factor and thrombosis. Further studies are needed to examine the role of vitamin D in cancer related thrombosis and other factors that may modulate TF expression in patient’s with PBC.

138 Does Timing/Delay of ERCP Affect Outcomes in Patients with Cholangitis?

Brandon Craft, MD, Peter Cotton, MD, Rob Hawes, MD, Christopher Lawrence, MD, Mark Payne, MD, Joseph Romagnuolo, MD, FACG. Department of Gastroenterology, Medical University of South Carolina, Charleston, SC. Purpose: Cholangitis can be a life-threatening problem. However, many patients defervesce quickly on antibiotics, are easily resuscitated, and appear to tolerate waiting for ERCP days later, at the same or different/tertiary institution. Some institutions have a policy of urgent/same-day or within-24h ERCP, while others are more conservative, esp. on weekends when routine support may be absent, and in sicker patients allowing for complete resuscitation first.

We tend towards the latter, but few published data support one approach over another.

Methods: We retrospective reviewed patients admitted/transferred to our facility with cholangitis, documented from a billing database, or with cholangitis as the indication/outcome of an ERCP in the Endoworks database. We included patients with clinical cholangitis: fevers, elevated white blood cell count, and evidence of biliary obstruction (biochemical/imaging). Our focus was straightforward causes of cholangitis (common duct stone, occluded stent, or extrahepatic stricture) more consistently helped with ERCP; we excluded surgically altered anatomy, sclerosing cholangitis, and intrahepatic stones.

Delay from time of presentation to ERCP was stratified into 4 groups: 0d delay, 1-2d, 2-5 days, or > 5 days.

Results: 53 patients met inclusion criteria; 43% had stones, and 28% had blocked stents. All patients were managed with IV fluid resuscitation and antibiotics awaiting ERCP, with a spectrum of regimens. 33 (62%) were inpatient transfers to our institution, after an average wait of 1.4 d (range: 0-13). The average time from presentation to ERCP was 2.61 d (range 0-17). 47 patients had fever, with 43 (81%) defervescing with antibiotics; 6 patients presented with pre-ERCP organ failure and an additional 4 developed post-ERCP organ failure. 1 death occurred (1%), and 6 (11%) patients were managed via an intensive care unit. 2 (3.8%) ERCPs were unsuccessful, and required PTC. 5 (9.4%) required repeat ERCP during their admission, and 2 (3%) adverse events occurred after ERCP, including 1 post-ERCP bleed, and 1 pneumonia.

There did not appear to be a significant difference regarding clinical outcomes including death (only death was in early group from withdrawal of care for cancer patient), organ failure (12% for earliest, 20% for latest groups; p = 0.7), or length of hospital stay (5-6 days) in patients undergoing ERCP for relief of obstruction at day 0, 1-2d, 2-5 days, or > 5 days.

Conclusion: In patients with ascending cholangitis, there does not appear to be a striking difference in outcomes between conservative management with antibiotics and intravenous fluids pending a delayed, semi-elective inpatient ERCP, versus earlier/urgent ERCP. Review of a larger cohort is ongoing.

The American Journal of Gastroenterology

139 Goff Trans-pancreatic Septotomy Is an Effective and Safe Biliary Cannulation Technique for Patients Who Fail Standard Biliary Cannulation Charles Liao, MD, Walter Park, MD, M.S., Ann Chen, MD, Shai Friedland, MD, Subhas Banerjee, MD. Stanford University, Stanford, CA. Purpose: Trans-pancreatic septotomy was described by Goff in 1995 as an alternative to free needle-knife (NK) pre-cut, to help achieve biliary access when standard cannulation techniques fail. It has been poorly evaluated, with only three other centers reporting their experience with this technique, two with <35 patients. This technique has been used exclusively as the primary advanced biliary access method at our institution, with the NK used only when the Goff technique fails. The purpose of this study is to define the technical success and complication rates associated with this procedure.

Methods: ERCP records between 2004-2010 were examined retrospectively, using a prospectively maintained endoscopy database. Patients undergoing Goff septotomy were identified. Goff septotomy was performed at our institution after four attempts at deep biliary cannulation failed. Demographic and clinical variables including indications for ERCP, outcomes including technical success and complications were collected.

Results: From a total of 4740 ERCP procedures performed during this time period by one endoscopist, 1124 individual patients undergoing ERCP for the first time were identified. Of these, 961 (85%) patients had successful biliary cannulation by traditional methods, NK sphincterotomy was performed in 45 patients (4%), percutaneous transhepatic cholangiography (PTC) in 10 patients (0.9%) and Goff septotomy was performed in 108 patients (9.6%). For the 108 patients undergoing Goff septotomy, the median age was 56 years (range 2088) with 53% patients female. Common indications for ERCP included choledocholithiasis (38%), bile duct strictures (36%) and abnormal LFTs following liver transplant (12%). Goff septotomy allowed successful biliary cannulation in 99 of 108 patients (success rate 92%, C.I.: 85-96%). Complications were noted in 8 patients (7.4%, C.I.: 4-15%). Pancreatitis developed in 4 patients (4%), self- limited oozing not requiring any intervention for hemostasis was noted in 2 patients, post procedural hypoxia in 1 patient and abdominal pain prompting an ER visit with a negative workup in 1 patient. There were no perforations, significant bleeds or procedure related deaths.

Conclusion: Transpancreatic septotomy is a highly efficacious technique for facilitating common bile duct cannulation when standard cannulation techniques fail, with success rates of 92% at our institution. In addition, it appears safe. Complication rates are lower than those reported in the literature for NK pre-cut techniques and similar to standard biliary cannulation techniques.

Further prospective randomized studies are warranted, comparing this technique to NK pre-cut in cases of difficult biliary cannulation.

140 Photodynamic Therapy in Nonresectable Cholangiocarinoma—Is It Worth It? Jaydeep Bhat, MD, MPH, Fadlallah Habr, MD. Gastroenterology, Alpert Medical School of Brown University, Providence, RI. Purpose: Cholangiocarcinoma carries a high mortality rate with only 20-30% of patients being surgical candidates at the time of diagnosis. The tumor causes significant morbidity with progressive obstruction of the biliary tree. Historically, survival in nonresectable cholangiocarcinoma has been 3-7 months.

Endoscopic biliary stenting, radiation, and chemotherapy are palliative interventions and do not prolong survival. Photodynamic therapy (PDT) may be a promising approach in the management of this disease. The goal of this study is to describe a single operator’s experience with PDT and evaluate survival rates compared to historical controls and quality of life at 3 months compared to baseline.

Methods: We performed a retrospective analysis of patients treated with PDT for nonresectable cholangiocarcinoma between 2006 and 2011 by the same

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[140] Table 1. Patient characteristics Subject

Age at Dx

Pre-PDT Tx

Time to PDT s/p dx (mos.)

Additional PDTs

Adj. Chemo s/p PDT

Radiation

Survival (mos.)

Stage of CA at dx

PDT Complications

1

61

stent

1

1

yes

yes

38 + (still alive)

metastatic

none

2

79

stent

2

2

yes

no

13

metastatic

retained PDT tip (subseq. retrieved); sunburn on RUE

3

46

stent x 3; chemo.

11

1

yes

no

22

metastatic

none

4

68

stent

0.5

none

yes

no

14

metastatic

none

5

33

stent

0.5

none

yes

no

3

locally advanced

none

6

62

none

0.5

none

no

no

1

metastatic

none

7

37

stent

0.5

none

yes

no

10 + (still alive)

metastatic

none

8

54

stent, chemo

4

none

no

yes

9

metastatic

none

operator. Patient demographics, medical records, and procedural data were reviewed. Karnovsky scores reflecting quality of life were determined at baseline and at 3 months. Statistical analysis, with means, standard deviations, and student’s t-test were performed.

Results: A total of 8 patients was identified. Mean age at the time of the procedure was 55 +/- 15.7 years. Seven patients had distant metastases, and one had locally advanced disease. All patients had biliary decompression with 1 to 3 plastic stents (Table 1). One had a self-expandable metal stent prior to the PDT. Six patients received adjuvant chemotherapy, and two had external beam radiation for portal vein invasion. Mean values for liver function tests before and after PDT are summarized in Table 2. Overall median survival in our sample was 11.5 months. Two patients died within three months: one from a myocardial infarction and stroke, and the other withdrew care after one chemotherapy cycle. Excluding those two patients, the median survival was 13.5 months. Two out of the eight patients are still alive, with one currently at 38 months since diagnosis. Six of the eight individuals had quality of life data available at baseline and 3 months after PDT. Median Karnovsky scores were 50 at baseline and 70 at 3 months, with a trend towards statistical significance (p = 0.06). PDT was largely uncomplicated as seen in Table 1.

Conclusion: Our study shows that PDT in conjunction with the current standard of care may be associated with prolonged survival and a low rate of complications in patients with nonresectable cholangiocarcinoma when compared with historical values. There was also a trend towards statistical significance in quality of life scores at three months compared to baseline. Our results are limited by the small sample size. Future randomized, controlled studies should be performed to further evaluate this modality.

Table 2. Liver function tests and quality of life measures following PDT

Methods: Cross-sectional study. Subjects with both MRI/MRCP and endoscopic pancreas function test (ePFT) for evaluation / management of chronic pancreatitis. Demographics (age, gender etc.), qualitative MRI features (parenchymal, ductal, secretory), and peak pancreas fluid [HC03] recorded. Qualitative MRI features independently scored [0 = no/absent, 1 = yes/present] by two abdominal imaging radiologists blinded to clinical data and pancreas function test results. Univariate analysis for association (chi square, t-tests) and multivariate analysis (logistic regression) for identification of independent predictors (covariates) of secretory dysfunction.

Results: 109 subjects between 2007 - 2011. A total of 47/109 (43.1%) had abnormal duct cell secretion (ePFT). Univariate analysis: Ten (10) statistically significant [p<0.05] radiologic features were identified: MRI parenchymal - atrophy [p<0.0001], decreased T1 signal [p<0.0001], decreased lobularity [p = 0.0008], delayed enhancement[p = 0.0013] and heterogenous enhancement [p = 0.021]; MRCP/sMRCP ductal - irregularity [p<0.0001], stricture [p<0.0001], filling defects [p<0.0001], > = 3 visible side branches [p = 0.002]and sMRCP secretory - ductal non-compliance [p = 0.0009]. Multivariate analysis(controlled for age/ gender): Four (4) statistically significant MRI covariates remained: decreased parenchymal T1 signal [p = 0.0008], glandular atrophy [p<0.0001], ductal irregularity [p<0.0001] and ductal non-compliance [p = 0.0009] (Table).

Conclusion: 1. Four (4) qualitative MRI/sMRCP features were independent predictors of pancreas secretory dysfunction 2. This data can be used as the qualitative imaging component of a clinical prediction model for diagnosing chronic pancreatitis 3. Clinical Implication: MRCP reporting must be standardized to accurately diagnose chronic pancreatic disease MRI Covariates identified as independent predictors of duct cell secretory dysfunction/chronic pancreatitis

Baseline

3 Months

AST

129.5

51.8 (P=0.05)

ALT

146

29 (P=0.08)

Bilirubin

7.1

1.9 (P=0.01)

Alk Phos

394.5

290.8 (P=0.27)

Ductal Covariates

50

70 (P=0.06)

Non-compliance

6.42

4.61, 8.23

Irregularity

8.88

6.04, 11.72

Quality of Life (Karnovsky score)

(LFT values reported in means; Karnovsky scores reported as medians).

MRI/sMRCPFeatures

Odds Ratio

[95% CI]

Decreased T1 signal

5.58

3.32, 7.84

Glandular Atrophy

7.54

4.98, 10.1

Parenchymal Covariates

141 Evaluation of Magnetic Resonance Imaging (MRI/sMRCP) Features for Diagnosis of Chronic Pancreatitis: Exploring Qualitative Covariates for a Clinical Prediction Model Darwin Conwell, MD, MS, Nisha Sainani, MD, Vivek Kadiyala, MD, Linda Lee, MD, Jessica Rosenblum, MPH, Joao Paulo, PhD, Peter Banks, MD, FACG, Koenraad Mortele, MD. Gastroenterology, Hepatology and Endoscopy, Harvard Medical School, Brigham and Women’s Hospital, Boston, MA. Purpose: Identify Qualitative MRI/ sMRCP imaging features that are associated with pancreas secretory dysfunction in assessment of chronic pancreatitis (CP)

© 2011 by the American College of Gastroenterology

142 Anomalous Pancreaticobiliary Junction in a North American Population: Clinical Findings and Outcomes Following ERCP Amer Alkhatib, MD, Kristen Hilden, RN, MS, Douglas Adler, MD, FACG. University of Utah, Salt Lake City, UT. Purpose: We report our findings and clinical outcomes in a North American series of patients with ABPJ undergoing ERCP. Methods: Retrospective chart review.

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Results: 2218 ERCP performed on 1050 patients were reviewed. 12 patients (1.1%) with ABPJ were identified (5F, 7M). No patient had an associated choledochocele. Mean age was 53.2 (range 17-85). A total of 43 ERCP procedures were performed on these 12 patients. All patients experienced passive pancreatography. No patient developed post-ERCP pancreatitis. Only 1 patient had a history of antecedent pancreatitis.

Conclusion: In North American patients undergoing ERCP, 1.1% of patients had ABPJ. Our study population was predominately Caucasian, male, and in all but one patient lacked a history of prior pancreatitis. No patient developed post-ERCP pancreatitis. This suggests that ABPJ may have different clinical manifestations in a North American population when compared to Asian populations.

The median PFS for patients with elevated baseline NSE (n = 104) compared to those without (n = 293) was 3.91 months elevated vs 8.08 months nonelevated (HR, 1.98: 95% CI, 1.52, 2.58; P < 0.001). In the everolimus arm, the median PFS for patients with elevated vs nonelevated baseline CgA was 8.54 and 11.17 months, respectively (HR, 1.20; 95% CI, 0.82, 1.77; P = 0.0346).

Median PFS for patients in the placebo arm with elevated vs nonelevated baseline CgA was 4.34 vs 4.90 months, respectively (HR, 1.34, 95% CI, 0.98, 1.84; P = 0.070). Median PFS was significantly shorter for patients with elevated NSE at baseline: 8.11 vs 13.86 months (HR, 2.04; 95% CI, 1.34, 3.11; P < 0.001) in the everolimus arm and 2.83 vs 5.36 months (HR, 2.04; 95% CI, 1.44-2.89; P = 0.011), respectively, in the placebo arm.

Conclusion: This largest, prospective, placebo-controlled, phase III trial of patients with advanced pNET demonstrates that elevated baseline biomarker levels correlate with shorter PFS. NSE appears to be a more robust prognostic biomarker than CgA in this disease. Everolimus provided a significant improvement in PFS regardless of baseline CgA and NSE biomarker levels.

Disclosure: Dr. Strosberg - Consultant for Novartis and research funds from Novartis. Dr. Anthony - Honoraria, advisory board, research funding - Novartis.

Dr. Sideris - research grants from: Novartis, Astra Zeneca, Roche and SanofiAventis; no stock. Dr. Lebrec - Employee Novartis Pharma AG; Consutant Novartis Pharma AG. Dr. Tsuchihashi - Employee of Novartis; no stock. Dr. Winkler - Employee of and stock in Novartis. Dr. Yao - Consultant or advisory role: Novartis, Ipsen, Pfizer, Endo; Honoraria: Novartis; Research funding: Novartis, Genentech.

This study was supported by Novartis.

144 Fluoroscopic image of an anomalous pancreaticobiliary junction.

143 Prognostic Value of Chromogranin A and Neuron-Specific Enolase in Patients with Advanced Pancreatic Neuroendocrine Tumors (pNET): Phase III RADIANT-3 Study Results 2011 ACG Presidential Poster Jonathan Strosberg, MD,1 Lowell Anthony, MD,2 Lucas Sideris, MD,3 Jeremie Lebrec, PhD,4 Zenta Tsuchihashi, PhD,5 Robert Winkler, MD,5 James Yao, MD6.

1. H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL; 2. Ochsner Kenner Medical Center, Kenner, LA; 3. Hôpital Maisonneuve-Rosemont, Montreal, QC, Canada; 4. SDE Services AG, Pratteln, Switzerland; 5. Novartis Pharmaceuticals Corporation, Florham Park, NJ; 6. The University of Texas MD Anderson Cancer Center, Houston, TX. Purpose: Elevated plasma CgA levels have been associated with poorer prognosis in patients with well-differentiated NET. In the phase III RADIANT-3 trial, everolimus provided a clinically and statistically significant 6.4-month improvement in PFS compared with placebo in patients with advanced pNET (Yao et al, NEJM 2011). This exploratory analysis evaluated changes in serum CgA and NSE levels over time and the prognostic value of these biomarkers for risk of disease progression.

Methods: A total of 410 patients with progressive, advanced low- or intermediate-grade pNET were randomly assigned to receive everolimus 10 mg/d orally (n = 207) or placebo (n = 203). The primary endpoint was PFS (RECIST v1.0).

Serum samples were collected and analyzed for CgA and NSE at baseline and, if elevated (>ULN), were repeated on day 1 of each 28-day cycle. Changes from baseline over time were analyzed using a mixed-effects model including least squares estimates and P values of treatment effect. For analysis of the prognostic power of these tumor markers, elevated baseline levels were defined as >2× ULN for CgA (ULN, 36.4 ng/mL) and >ULN for NSE (ULN, 8.6 ng/mL).

Results: Elevated baseline levels of CgA and NSE levels were each associated with shorter median PFS. Overall, the median PFS for patients with elevated baseline CgA (n = 187) compared to those without (n = 218) was 5.55 months elevated vs 7.98 months nonelevated (HR, 1.34: 95% CI, 1.10, 1.78; P = 0.006).

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Cigarette Smoking Impairs Pancreatic Duct Cell Function Vivek Kadiyala, MD,1 Peter Banks, MD, FACG,1 Linda Lee, MD,1 Jessica Rosenblum, MPH,1 Joao Paulo, PhD,2 Nisha Sainani, MD,1 Koenraad Mortele, MD,1 Darwin Conwell, MD, MS1. 1. Brigham and Women’s Hospital, Brookline, MA; 2. Children’s Hospital Boston, Boston, MA. Purpose: To assess pancreas function in subjects with and without cigarette smoking exposure (current and past), comparing peak bicarbonate concentration ([HCO3]) in pancreas fluid (PF) and pancreatic elastase-1 (PE-1) in stool.

Methods: Cross sectional study. Data collection form developed to record demographics (age, gender etc.), smoking status (former, current, never), alcohol intake, clinical data (imaging, endoscopy) and laboratory studies (PF [HCO3] and stool PE-1) from subjects evaluated for pancreatic disease.

Normal PF [HCO3]≥75 meq/L and normal PE-1>200 ug/g. Univariate and multivariate statistical analysis (SPSS v. 16.0) performed to assess relationship between cigarette smoking exposure and pancreas function.

Results: Smoking and Duct Cell Secretory Function: A total of 131 subjects underwent ePFT, for pancreas fluid bicarbonate analysis. 74/131 (56.5%) subjects smoked and 57/131 (43.5%) never smoked. Measures of Association: Cigarette smoking exposure was found to be associated with abnormal ePFT result (M-H x2 = 12.05, p = 0.0005). Furthermore, there was no statistical difference in peak [HCO3] between past and current smokers (M-W U = 624.50; p = 0.572). Risk-Based Estimates: The risk of duct cell secretory dysfunction in former or current smokers was 56.78% [45.41, 67.44], and 26.32% [16.55, 39.07] in non-smokers. The risk ratio was 2.1 [1.34, 3.48] when smokers were compared to non-smokers. Multivariate Analysis: Controlling for age, gender and alcohol intake (≥20gm/day; ≥2 drinks/day), smoking exposure was found to be an independent predictor of abnormal peak PF [HCO3] (OR 4.05 [1.79, 9.16]; p = 0.001) (Table). Smoking and Acinar Cell Exocrine Function: A total of 61 subjects underwent stool PE-1 testing. No significant association was found between smoking exposure and acinar cell exocrine dysfunction (M-H x2 = 0.74, p = 0.39).

Conclusion: 1) Smoking exposure is associated with pancreatic duct cell secretory dysfunction, independent of age, gender and alcohol intake. 2) Smoking exposure was not found to be associated with stool PE-1. This may be due to the low sensitivity of stool PE-1 in detecting mild acinar cell dysfunction. 3) Smoking cessation is strongly advised as part of long term CP management.

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146

[144] Smoking and significant alcohol consumption are independent predictors of abnormal PF peak [HCO3], controlling for age and gender Co-variate

Estimate

Odds Ratio

P-value

Smoking (past & current)

1.399

4.05 [1.79, 9.16]

0.001

Age

0.018

1.02 [1.05, 1.01]

0.205

Gender

0.636

1.89 [1.20, 4.27]

0.127

Alcohol Intake*

0.939

2.56 [1.00, 6.54]

0.050

*Increased/Excessive alcohol intake (20gm/day; 2 drinks/day).

145 Updated Results from the Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Trial (RADIANT-3) of Everolimus in Patients with Advanced Pancreatic Neuroendocrine Tumors (pNET) Edward Wolin, MD,1 Rodney Pommier, MD,2 Jeremie Lincy, PhD,3 Robert Winkler, MD,4 James Yao, MD5. 1. Cedars-Sinai Medical Center, Los Angeles, CA; 2. Oregon Health & Science University, Portland, OR; 3. Novartis AG, Basel, Switzerland; 4. Novartis Pharmaceuticals Corporation, Florham Park, NJ; 5. The University of Texas MD Anderson Cancer Center, Houston, TX. Purpose: Treatment of pancreatic neuroendocrine (pNET) tumors represents a challenge for clinicians due to the limited number of effective treatments for controlling disease progression in patients with advanced disease. Estimated median overall survival (OS) for treatment-naive patients with metastatic disease is 24 months (Yao et al, 2008). In the phase III RADIANT-3 trial, everolimus, an oral mTOR inhibitor, provided a statistically significant 2.4-fold improvement in progression-free survival (PFS) vs placebo (Yao et al, NEJM 2011). Based on these findings, everolimus received approval by the FDA in May 2011 for the treatment of progressive pNET that is unresectable, locally advanced, or metastatic. An updated analysis of the survival and safety from this trial is presented.

Methods: Patients with progressive advanced low- or intermediate-grade pNET were randomly assigned to everolimus 10 mg/d orally (n = 207) or placebo (n = 203); both arms received best supportive care. Primary endpoint was PFS (RECIST v1.0). Upon disease progression, patients assigned to placebo could cross over to open-label everolimus. The cutoff date for this updated analysis was February 23, 2011. As of this date, a total of 146 deaths occurred: 68 everolimus; 78 placebo. Adverse events (AEs) were coded to a preferred term and graded using the National Cancer Institute Common Toxicity Criteria (v3.0).

An updated safety analysis was performed on June 3, 2010; the safety population included 407 patients (204 everolimus; 203 placebo).

Results: At the time of this updated analysis, 172 (85%) of the 203 patients in the placebo group crossed over to open-label everolimus. Thus, the majority of patients might have benefited from everolimus. Median OS was 36.6 months in the placebo arm and has not been reached in the everolimus arm (HR, 0.89; 95% CI, 0.64-1.23). Median safety follow-up now extends to 20.1 months.

The most common drug-related AEs (all grades) with everolimus vs placebo remained stomatitis (52.9% vs 12.3%), rash (48.5% vs 10.3%), and diarrhea (34.3% vs 10.3%). Anemia (5.9% vs 0%), hyperglycemia (5.9% vs 2.5%), and stomatitis (4.9% vs 0) were the most common drug-related grade 3/4 events for everolimus and placebo, respectively.

Conclusion: In the RADIANT-3 trial, median OS has not been reached in the everolimus arm. Median OS in the placebo arm, in which substantial crossover occurred to open-label everolimus, exceeds the median previously observed for patients with metastatic pNET. The safety of everolimus observed in this analysis was consistent with previous experience. Final survival analysis will be completed after 282 events.

Disclosure: Dr. Wolin - Advisory Board Novartis. Dr. Pommier - No conflict of interest. Dr. Lincy - Employee of Novartis; no stock. Dr. Winkler - Employee of and own stock in Novartis. Dr. Yao - Consultant or advisory role: Novartis, Ipsen, Pfizer, Endo; Honoraria: Novartis; Research funding: Novartis, Genentech.

This research was supported by an industry grant from This study was supported

by Novartis. © 2011 by the American College of Gastroenterology

Cannulation Success and Complications When Performing Precut ­Sphincterotomy Using a Needle-Knife Converted from a Standard Biliary Sphincterotome Nayantara Coelho-Prabhu, MD, Todd Baron, MD, FASGE. Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN. Purpose: Most endoscopists now attempt cannulation with a biliary sphincterotome (BS) and guidewire. If unsuccessful, access sphincterotomy is then performed, most often with a needle-knife (NK). This entails additional cost and may not be necessary if a sphincterotomy was not intended. There are reports of converting a BS into a NK but no data on its effectiveness. Aim: To determine whether there was a difference in success and complications using a converted NK compared to standard NK for precut biliary sphincterotomy.

Methods: After failed cannulation using a BS and guidewire, the cutting wire was cut at its most distal portion to free the wire. The catheter was trimmed close to where the proximal end of the wire exits. This converted NK was then used to perform precut sphincterotomy using an ERBE generator at standard settings. Standard NKs were used if anticipated extension of the sphincterotomy was required. Patients were identified from a database that recorded all accessories used by one experienced biliary endoscopist. A nested case-control study was performed. Chart review was performed for outcome. Success was defined as deep and selective cannulation of the bile duct. Adverse events were defined using standard criteria.

Results: 631 patients underwent ERCP over a 4 year period of time. 455 patients underwent standard biliary sphincterotomy without need for precut.

34 underwent precut using a converted triple lumen NK (Olympus CleverCut™) with a guidewire and 142 using a standard NK (Cook Endoscopy) assisted with cannulation of BS with guidewire, as needed. We chose 34 controls from the standard NK group, matched by date to within 30 days of the case date. Cannulation was successful in 33 patients (97%) using the converted NK. in some patients another BS was used for additional cannulation and/or extension of the precut site if needed. Cannulation was successful in 31 patients (91%) using the standard NK. Complications of immediate bleeding, pancreatitis and perforation were 2.9%, 5.8%, and 0% in the converted NK group and 14.7%, 5.8%, and 5.8%, in the standard NK group. No delayed bleeding occurred. Pancreatic duct stents were used in 32.3% in each group. The differences in success rate and complications were not statistically significant between the groups, likely due to small sample size.

Conclusion: Needle-knives converted from standard biliary sphincterotomes are safe and effective in achieving deep cannulation. Conversion of a standard biliary sphincterotome to a needle knife allows successful cannulation equal to that of a standard needle knife when standard cannulation fails, and with similar complications when used by experienced endoscopists. This may result in significant cost-savings for a busy endoscopy unit.

147 Cigarette Smoking Impacts Chronic Pancreatitis Clinical Feature Score, Severity Index and Imaging Severity Vivek Kadiyala, MD,1 Peter Banks, MD, FACG,1 Linda Lee, MD,1 Jessica Rosenblum, MPH,1 Joao Paulo, PhD,2 Nisha Sainani, MD,1 Koenraad Mortele, MD,1 Darwin Conwell, MD, MS1. 1. Brigham and Women’s Hospital, Brookline, MA; 2. Children’s Hospital Boston, Boston, MA. Purpose: To assess chronic pancreatitis (CP) disease severity in subjects with and without cigarette smoking exposure, using the M-ANNHEIM classification system.

Methods: Cross sectional study. Data collection form developed to record demographics (age, gender etc.), smoking status (former, current, never), alcohol intake, clinical data (imaging, endoscopy, symptoms) and laboratory studies (peak PF [HCO3] and stool PE-1) from subjects evaluated for pancreatic disease. M-ANNHEIM CP clinical feature score (0-24), severity index (grade A-E) and morphologic (imaging) changes (normal-marked changes) determined. Univariate statistical analysis (SPSS v. 16.0) performed to assess relationship between cigarette smoking exposure and CP clinical severity.

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Results: A total of 131 CP patients underwent ePFT, for pancreas fluid PF bicarbonate analysis. 74/131 (56.5%) subjects were smokers (former or current) and 57/131 (43.5%) had never smoked. 31/131 (23.7%) of subjects consumed increased/excessive alcohol (≥20 gm/day or ≥2 drinks/day) and 99/131 (75.6%) consumed less than 20 grams, or none at all. M-ANNHEIM Clinical Feature Score: Increased clinical feature scores were associated with cigarette smoking exposure (p<0.001), but not with increased/excessive alcohol intake (p = 0.361). M-ANNHEIM Severity Index: Increased severity index was associated with cigarette smoking exposure (p<0.001), but not with increased/excessive alcohol intake (p = 0.407). M-ANNHEIM Morphologic Imaging Changes: Cigarette smoking (p = 0.0156) and increased/excessive alcohol intake (p = 0.0137) were both associated with increased risk of moderate/marked imaging changes (TABLE).

Conclusion: 1) Smoking exposure, but not alcohol, was associated with increased M-ANNHEIM CP clinical feature score and severity index grade.

2) Both alcohol and smoking exposure were associated with marked/moderate changes on radiologic imaging. 3) Given the effect of smoking on CP symptoms, severity and imaging, smoking cessation is strongly advised as part of both acute and long term CP management.

Smoking M-ANNHEIM

Alcohol Intake*

Value

Significance

Value

Significance

Clinical Feature Score

M-W U=1147.00

P < 0.001

M-W U=1368.00

P=0.361

Clinical Severity Index

M-W U=1223.50

P < 0.001

M-W U=1393.50

P=0.407

Moderate/Marked Morphologic Changes

H-M x2=5.84

P=0.0156

H-M x2=6.08

P=0.0137

*Increased/excessive alcohol intake (≥20 gm/day; ≥2 drinks/day).

148 Photodynamic Therapy for Unresectable Cholangiocarcinoma: A Comparative Effectiveness Systematic Review and Meta-analyses Cadman Leggett, MD, Mohammad Murad, MD, Victor Montori, MD, Kenneth Wang, MD, FACG. Internal Medicine, Mayo Clinic, Rochester, MN. Purpose: Photodynamic therapy plus biliary stenting (PTBS) is increasingly being used as a palliative measure for advanced cholangiocarcinoma (CCA).

Its effects on survival and functional status remain unclear. The purpose of this systematic review was to determine the relative effectiveness of PTBS in the palliative treatment of CCA compared to biliary endoprothesis placement alone.

Methods: Several databases were searched from inception until September 2009 for original longitudinal studies that enrolled patients with CCA who received PTBS (with a protoporfirin derived photosensitizer) as the principle palliative intervention compared to placement of either plastic or metal biliary endoprotheses. Outcomes of interest included patient survival, quality of life (as measured by the Karnofsky index), and serum bilirubin levels. A subgroup analysis evaluated the interaction between the length of diffuser tip employed and the effect of treatment allocation on survival. The relative risk (RR) for dichotomous outcomes and the weighted mean difference (WMD) for continuous outcomes were estimated using the DerSimonian and Laird randomeffects model. Inconsistency was quantified using the I2 statistic. The extent of publication bias was ascertained by visually inspecting funnel plots and conducting Egger’s regression test.

Results: Six studies (2 randomized trials) met inclusion criteria. A total of 174 participants received PTBS and 150 received biliary endoprothesis as a control group. Both groups were comparable with regard to age, gender and Bismuth scale for CCA. Compared with biliary endoprothesis placement alone, PTBS was associated with a statistically significant increase in the length of survival (WMD 261.43 days; 95% CI, 138.20, 384.66; p = 0.01; I2 = 87%) and Karnofsky scores (WMD 7.73; 95% CI, 3.47, 11.99; p = 0.01; I2 = 0%), and a decrease in serum bilirubin (WMD -3.25 mg/dL; 95% CI, -5.59, -0.90; p = 0.01; I2 = 0%).

Subgroup analysis showed a trend toward increased survival when fiber length was more than 2 cm (compared with ≤ 2 cm). Due to the small number of included studies, statistical analyses for publication bias were not feasible.

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Conclusion: The present study demonstrates promising benefits of PTBS for palliative treatment of cholangiocarcinoma on survival, biliary drainage and quality of life. A multi-center randomized controlled trial with a large sample size and adequate allocation concealment is necessary to confirm this observation. Longitudinal follow-up since time of diagnosis is also necessary to determine the most appropriate time to commence photodynamic therapy. Patients may benefit from longer fiber lengths to treat extensive disease.

149 Elevated BISAP Score Is Associated with Early Unplanned Readmission in Acute Pancreatitis (AP) Amit Bhatt, MD, Jordan Holmes, MD, Rocio Lopez, MS, MPH, Maged Rizk, MD, Tyler Stevens, MD. Gastroenterology, Cleveland Clinic Foundation, Cleveland, OH. Purpose: (AP) is a frequent cause of hospital admission. Early unplanned readmissions place significant burden on the health care system and have been identified as a target for quality improvement. The aim was to identify risk factors for early-unplanned readmission in AP. Methods: This retrospective study identified 193 consecutive patients presenting with AP to the emergency department (ED) at a single large tertiary referral center between 01/2008 and 05/2010. Demographic, clinical, radiographic and laboratory data was collected from all patients. Early readmission was defined as rehospitalization or re-evaluation in ED within 30 days of initial hospitalization of AP that was not previously planned.

Results: Of 193 patients, 28 (15%) were readmitted within 30 days. Patients were readmitted due to abdominal pain (75%), nausea ( 14.3%),vomiting (17.9%), and other symptoms (35.7%). 6 (21.4%) met criteria for recurrent pancreatitis on readmission. Of patients readmitted, 11(42.3%) had followup appointments scheduled on initial hospitalization, and 6 were seen in the outpatient clinic prior to readmission. On univariable analysis, neither age, gender, race, Charlson co-morbidity index, chronic pancreatitis, length of stay nor etiology were associated with early readmission. BUN, systemic inflammatory response syndrome (SIRS) and BISAP scores on day 2 were associated with early readmission. On multivariable analysis BISAP score on day 2 was associated with early readmission with an odds ratio 2.8 (1.3, 5.8 p = 0.008).

For each point increase in BISAP score on day 2, the likelihood of being readmitted within 30 days is 3 times higher (p = 0.008). The area under the ROC curve for this model was estimated to be 0.80 (95% CI: 0.70, 0.91), indicating good prediction (Figure 1).

Conclusion: Elevated BISAP score during hospitalization is strongly associated with early unplanned readmission. Close outpatient follow up should be considered in this patient group after discharge.

Figure 1: BISAP score Day 2: Prediction of Early Readmission: Receiver Operating Characteristics Curve.

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Abstracts

150 Gastroesophageal Varices as a Complication of Pancreatic Carcinoma Eric Nelsen, MD, Peter Stanich, MD, Louis Wong Kee Song, MD, John Park, MD. Mayo Clinic, Rochester, MN. Purpose: Gastroesophageal varices are a rare complication of pancreatic carcinoma. Data regarding patient characteristics, tumor features, and outcomes in this patient population are scant and limited to case reports. To assess the clinical features and outcomes of patients with pancreatic cancer complicated by gastroesophageal varices.

Methods: The medical records of all patients with biopsy-proven pancreatic carcinoma and endoscopic evidence of gastroesophageal varices seen at our institution from 1/2006 to 12/2008 were reviewed retrospectively. Patients with concomitant cirrhotic portal hypertension were excluded. Data was abstracted for patient demographics, clinical and tumor characteristics, imaging and endoscopic features, and patient outcomes.

Results: A total of 17 patients (10 males; mean age 60.6 (range 27-81)) were found to have pancreatic carcinoma and gastroesophageal varices. The tumor types were adenocarcinoma in 53%, neuroendocrine tumors in 41%, and acinar cell in 6% of patients. Splenic and/or portal vein thromboses were documented in 11 (65%) patients by imaging studies (EUS and/or CT). Gastroesophageal varices occurred as isolated esophageal varices, isolated gastric varices, and esophago-gastric varices in 31%, 25%, and 44% of patients, respectively. Six of the 17 (35%) patients had clinically significant bleeding episodes from the gastroesophageal varices (3 esophageal, 3 gastric); 5 patients were treated endoscopically (2 with cyanoacrylate injection, 1 with ethanolamine injection, and 2 with variceal banding). The overall mean survival after diagnosis of varices was 1.85 (range 0.05-7.56) years. Mean survival for neuroendocrine/acinar patients was 2.83 years versus 1.1 years for patients with adenocarcinoma (p = 0.08).

Conclusion: To our knowledge, this is the largest series reported to date regarding pancreatic cancer complicated by gastroesophageal varices. In our patient population, the occurrence of variceal bleeding was high and a significant proportion of tumors (41%) were of the neuroendocrine type, even though they account for only 5% of all pancreatic carcinomas.

151 Adherence to Evidence-based Management of Acute Pancreatitis (AP) Amit Bhatt, MD, Jordan Holmes, MD, Rocio Lopez, MS, MPH, Charles Winans, MD, Matthew Walsh, MD, Tyler Stevens, MD. Gastroenterology, Cleveland Clinic Foundation, Cleveland, OH. Purpose: AP is a common indication for hospital admission. High quality research and major society guidelines are available to guide the management of AP. Our aim was to compare adherence to evidence-based management of AP on medical and surgical hospital services at a single U.S. center.

Methods: This retrospective study identified 203 consecutive patients who presented with definite AP to the emergency department (ED) at a single large referral center between 01/2008 and 05/2010. Demographic, clinical, radiographic and laboratory data was collected from all patients. We assessed adherence to the following evidence-based best practices: 1. Avoidance of CT scans in the first 48 hours after symptom onset, 2 Documentation of a severity score (e.g. Ranson, BISAP), 3. Early aggressive fluid resuscitation (>4,800 ml in first 24 hours), 4. Performance of etiology workup [triglycerides, right upper quadrant (RUQ) ultrasound], 5. Avoidance of serial amylase/lipase. We compared compliance to these best practices between the different hospital services, including the clinical decision unit (CDU), our emergency department observation unit.

Results: 203 patients with AP were reviewed. Overall adherence was less than 50% for most of the best practices [Figure 1]. There were no significant differences in adherence between the inpatient hospital services; however, significantly lower adherence was noted in the CDU for several best practices [Table 1].

Conclusion: Adherence to evidence-based management of AP was suboptimal at our hospital. Quality improvement programs are underway.

© 2011 by the American College of Gastroenterology

[151] Table 1. Adherence

N

Overall (N=203)

General Surgery (N=8)

Internal Medicine (N=98)

Gastroenterology (N=41)

CDU (N=43)

No CT scan in first 48 hours

166

75 (45.2)

4 (66.7)

29 (37.2)

21 (58.3)

19 (52.8)

Severity Score documentation

174

44 (25.3)

0 (0.0)

28 (35.4)4

11 (31.4)

3 (7.1)2

At least 4800cc for 1st 24 h

202

73 (36.1)

2 (25.0)

37 (37.8)

21 (51.2)4

8 (19.0)3

triglycerides checked in first or unknown AP

135

43 (31.9)

0 (0.0)

28 (44.4)4

11 (42.3)4

2 (6.3)23

RUQ US performed

203

94 (46.3)

5 (62.5)

56 (57.1)4

17 (41.5)

9 (20.9)2

Factor

1: Significantly different from General Surgery, 2: Significantly different from Internal Medicine, 3: Significantly different from Gastroenterology, 4: Significantly different from CDU A significance level of 0.003 was used for pairwise ad-hoc comparisons.

[151] Figure 1

152 Molecular Markers of Malignant Transformation in IPMN and MCN of the Pancreas: A Meta-Analysis of Cyst Aspirate and Juice Studies Gregory Idos, MD, Sahar Nissim, MD, Bechien Wu, MD,MPH. Brigham and Women’s Hospital, Boston, MA. Purpose: Intraductal papillary mucinous neoplasms (IPMN) and mucinous cystic neoplasms (MCN) of the pancreas have the potential to progress to invasive adenocarcinoma. Numerous studies have characterized genetic mutations found in cyst aspirate and juice in an attempt to enhance the pre-operative diagnosis of malignancy. However, the ability of genetic markers to detect malignancy remains controversial. Our aim was to determine the risk of malignant transformation associated with specific genetic abnormalities detected in either cyst aspirate or juice.

Methods: We conducted a quantitative meta-analysis reviewing Pubmed, Cochrane, and Embase databases from 1996 thru 2011. We included only studies that analyzed gene expression in IPMN and MCN cyst aspirate or juice.

Malignant cysts were classified according to 1996 World Health Organization criteria. Genetic markers included in at least 3 studies were incorporated into the quantitative meta-analysis.

Results: We identified a total of 17 studies that satisfied the inclusion criteria representing 246 cyst samples (190 cyst aspirates and 156 pancreatic juice).

In pooled analysis there was an increased risk of malignancy with telomerase mutations (OR 8.43; 95% C.I. 2.72-26.16, sensitivity 56-80%, specificity 71-80%) in IPMN cyst juice. Mutation of K-ras was not associated with malignancy (OR 1.59; 95% C.I. 0.26-9.26, sensitivity 50-100%, specificity 7-40%) nor was p16 (OR 0.69; 95% C.I. 0.12-3.99, sensitivity 0%- 14%, specificity 67% -100%). Also, K-ras mutation in cyst aspirate was not associated with risk of a malignant cyst (OR 1.76; 95% C.I. 0.87-3.53, sensitivity 25%-91%, specificity 17%-93%).

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Conclusion: The most studied genetic mutations in pancreatic cyst aspirate and juice were Kras followed by by telomerase and p16. In this meta-analysis, presence of Kras mutation was not significantly associated with increased risk of malignancy. However, we identified telomerase mutation as the molecular change associated with the greatest risk for IPMN progression to cancer. This association provides basis for further study of telomerase as a biomarker for pre-operative risk stratification of IPMN.

153 Underutilization of Hepatitis C-Positive Allografts in Simultaneous Pancreas-Kidney Transplantation Jorge Ortiz, MD, John Gunselman, DO, Stalin Campos, MD, Kamran Khanmoradi, MD, Radi Zaki, MD. Albert Einstein Medical Center, Philadelphia, PA. Purpose: Simultaneous pancreas-kidney transplant (SPKT) for Type 1 diabetics on dialysis has long been the gold standard. Although the use of hepatitis C viruspositive (HCV(+)) donors in kidney transplantation alone (KTA) is well studied, data on HCV(+) SPKT recipients are not robust. A recent review reported that recipient HCV infection had no significant impact on acute rejection rates or patient survival in SPKT but the utilization of HCV(+) organs was negligible.

Our objective was to determine utilization rates for HCV(+) SPKT allografts, evaluate outcomes of these transplantations and determine reasons for non-use.

Methods: The Organ Procurement and Transplant Network / United Network for Organ Sharing (OPTN/UNOS) database was employed to obtain information regarding HCV(+) and HCV-negative (HCV(-)) SPKT recipients. We assessed outcomes of SPKT using HCV(+) organs and explored the disposition of donor pancreata.

Results: Between 2000 and January 2011, 702 of 25,904 donors (2.7%) were HCV(+) and met otherwise ideal criteria. We identified only 16 patients who received HCV(+) organs for SPKT between 1995 and 2010. Four had kidney allograft losses, all due to chronic rejection. Six had pancreatic allograft losses: one due to pancreatitis, one to infection, one to chronic rejection, one to acute rejection and two to graft thrombosis. None of the sixteen patients were subsequently listed for liver transplantation. Of the 2,314 candidates waitlisted for SPKT 23 (1.1%) have indicated that they would accept HCV(+) organs.

Conclusion: 16 patients have undergone SPKT with HCV(+) organs with acceptable results. More aggressive use of HCV(+) organs for SPKT would lead to earlier transplantation for HCV(+) recipients and increased availability of HCV(-) organs for HCV(-) recipients.

154 Diagnostic and Therapeutic Impact of Intraductal Ultrasound and Transpapillary Endoscopic Biopsies in Ampulla of Vater Tumors Philipp Lenz, MD,1 Hauke Heinzow, MD,1 Sonja Lallier, Cand. med.,1 Frank Lenze, MD,1 Dirk Domagk, MD, PhD,1 Wolfram Domschke, MD, PhD,1 Tobias Meister, MD2. 1. Department of Medicine B, University of Muenster, Münster, Germany; 2. Helios Albert-Schweitzer-Klinik, Northeim, Germany.

Purpose: The study was designed to evaluate the diagnostic impact of intraductal ultrasound (IDUS) and endoscopic transpapillary forceps biopsies (ETP) in ampullary tumors.

Methods: Seventy-two patients with suspected ampullary tumor were examined by ERCP, including IDUS and ETP. Final diagnosis revealed ampullary adenoma in 40 patients and ampullary carcinoma in 32 cases. Sensitivity, specificity and accuracy rates for each of the diagnostic measures were calculated including T and N stage accuracy.

Results: Four carcinomas were misclassified by IDUS giving sensitivity, specificity and accuracy rates of 87.5%, 92.5% and 90.2%, respectively. Using ETP, a correct pre-interventional diagnosis of ampullary carcinoma was achieved in 22 out of 32 patients resulting in a sensitivity, specificity and accuracy data of 68.7%, 100% and 86%, respectively. Improvement of sensitivity and accuracy to 97% and 94.5%, respectively, could be achieved by IDUS in combination with ETP. IDUS accuracy for T1, T2 and T3 stages was 86%, 71% and 86%, respectively. For N0 and N1 stages accuracy of 75% each was calculated.

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Conclusion: IDUS+ETP substantiate the diagnosis and further management of ampullary tumors. ETP alone is not useful in detecting malignancy (false-negative rate of 31.3%). IDUS accurately predicts T and N stages in patients and is able to accurately predict cases potentially treatable endoscopically.

155 Feasibility of Snare Papillectomy in Ampulla of Vater Tumors: Metaanalysis and Study Results from a Tertiary Referral Center Philipp Lenz, MD,1 Hauke Heinzow, MD,1 Frank Lenze, MD,1 Dirk Domagk, MD, PhD,1 Wolfram Domschke, MD, PhD,1 Tobias Meister, MD2.

1. Department of Medicine B, University of Muenster, Münster, Germany; 2. Helios Albert-Schweitzer-Klinik, Northeim, Germany.

Purpose: Ampulla of Vater tumors represent a rare tumor entity with malignant potential following the adenoma-carcinoma sequence. Possible diagnostic options include endoscopic transpapillary forceps biopsies (ETP) and endoscopic snare papillectomy (ESP). This study aimed to evaluate the feasability of ESP and long-term endoscopic surveillance at our tertiary referral center in comparison to results of a met-analysis of comparative trials.

Methods: 21 patients (mean age 60.2±12.8 years) with ampullary adenoma could be included in the study. All patients had undergone ERCP with ETP prior to ESP. Statistical analysis was applied including descriptive analysis for symptoms, therapy and complications in comparison to results of a met-analysis of comparative trials.

Results: ESP was technically successful in all 21 patients. Histopathology of the papillectomy specimen showed 18 adenomas and 3 focal adenocarcinomas which were referred to surgery for modified Whipple procedure. Follow-up (f/u) was available in all patients with mean f/u of 64 months. Adenoma recurrence occurred in three patients with a mean recurrence time of 25 months (range 4 - 66). One patient had residual adenoma growth.

Conclusion: In the majority of cases ampullary adenomas can be treated endoscopically. ETP alone is not useful in detecting malignancy (false-negative rate of 15%). All patients with ampullary tumor should therefore undergo ESP. Due to the recurrence rate of 16% patients should have close follow-up.

156 Favorable Outcomes with Conservative Management in Patients with Emphysematous Pancreatitis and Spontaneous Intestinal Fistulization Pardeep Bansal, MD, David Diehl, MD, FASGE, Joseph Blansfield, MD, FACS. gastroenterology, Geisenger Health System, Danville, PA. Purpose: Emphysematous pancreatitis (EP) is characterized by the presence of intraparenchymal pancreatic air in the setting of necrotizing pancreatitis. Traditionally, EP has been an indication for surgical intervention. We encountered three patients with EP, all with spontaneous small bowel fistula, who did well with conservative management alone.

Methods: Case series of 3 cases of EP. Results: Case 1. A 37 year old male brought to ER with altered mental status and CT scan showed severe pancreatitis. He was managed with supportive care. After 4 weeks patient developed jaundice and CT scan of abdomen showed hemorrhagic pancreatitis, and he underwent ERCP with stent placement. A repeat ERCP after 6 weeks for stent exchange showed a large fistula near major papilla and CT showed EP. Patient continued to be managed conservatively. Now after 1 year his EP has resolved. Case 2. 49 yr old with PMHx of pancreatitis 4 weeks ago came with epigastric pain and found to have lipase of over 10,000 U/L. CT showed severe pancreatitis with areas of necrosis and emphysematous changes. EUS showed a duodenal fistula. He was treated conservatively without antibiotics. 4 weeks later, repeat CT showed significant improvement in EP. He underwent cholecystectomy and now after 2 years his EP has completely resolved. Case-3: 57-year-old male who came to ER with epigastric distress and found to have an ST elevation myocardial infarction and CT scan of abdomen showed pancreatitis. Repeat CT after 4 weeks showed air in the pancreas, although he was feeling well. After 6 weeks of his CT scan, he Volume 106 | supplement 2

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had an episode of GI bleeding; an EGD showed a bleeding fistula between the pancreas and duodenum. Follow up CT scan in 1 year from his initial episode of pancreatitis showed complete resolution of EP. Conclusion: Traditionally EP is managed by surgical debridement which has mortality of 25%, and morbidity of 100%. Our case series suggests that patients with EP who are not septic or critically ill may have developed spontaneous fistulas and might be good candidates for conservative management.

Case 1: Patient with emphysematous pancreatitis and spontaneous intestinal fistulization who mas managed conservatively.

158 Clinical Outcomes Compared Between Laparoscopic and Open Distal Pancreatectomy for Benign Tumors Jun Chul Chung, MD, PhD. Surgery, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.

Purpose: Though laparoscopic distal pancreatectomy for benign conditions was first described in the early 1990s, there is limited information on the outcomes of the laparoscopic surgery compared with open surgery. Therefore, this study aimed to investigate the clinical outcomes and to evaluate efficacy of laparoscopic distal pancreatectomy compared with open distal pancreatectomy in the benign or borderline malignant tumors.

Methods: From June 2001 to December 2008, 17 patients underwent laparoscopic distal pancreatectomy, and 26 patients underwent open distal pancreatectomy at our institute. Among 17 patients who underwent laparoscopic distal pancreatectomy, 5 cases (malignancy cases = 2, enucleation cases = 3) were excluded. Among 26 patients who underwent open distal pacreatectomy, 13 cases (trauma cases = 6, malignancy cases = 7) were excluded.

Results: Laparoscopic distal pancreatectomy is equivalent to open distal pancreatectomy in operation time, rate of transfusion, rate of pancreatic leakage, and mortality. But, laparoscopic distal pancreatectomy is superior to open distal pancreatectomy in blood loss (p = 0.002), time to oral intake (p = 0.013), and time to first flatus (p = 0.003).

Conclusion: Laparoscopic distal pancreatectomy is a clinically safe and effective procedure for benign and borderline malignant pancreatic tumors.

157

159

Body Mass Index - A Risk Factor for Acute Gallstone Pancreatitis in Hispanic Patients with Common Bile Duct Stones Gautamy Chitiki Dhadham, MD,1 Walid Baddoura, MD, FACG,3 Vincent Debari, Ph.D2. 1. Internal Medicine, St Joseph’s Regional Medical Centre, West Paterson, NJ; 2. Seton Hall University of Health and Medical Sciences, South Orange, NJ; 3. Division of Gastroenterolgoy, St Joseph’s Regional Medical Centre, Paterson, NJ.

Single Balloon Enteroscopy (SBE) Assisted Endoscopic Retrograde Cholangiopancreatography (ERCP) in Patients with Surgically Altered Anatomy: A High Volume Academic Center Experience Yutaka Tomizawa, MD, Andreas Gelrud, MD, MMSc. University of Pittsburgh Medical Center, Pittsburgh, PA.

Purpose: To retrospectively analyze all the Hispanic patients who had undergone endoscopic retrograde cholangiopancreatography (ERCP) for common bile duct (CBD) stones/debris and compare patients with gallstone pancreatitis and those without pancreatitis with CBD stones.

Methods: Medical records of all the Hispanic patients who had undergone ERCP between January 01 2006- December 31 2009 were reviewed and data such as demographics, body mass index (BMI), initial laboratory values such as amylase and lipase levels, ultrasound findings and ERCP findings were noted.

All the patients who had CBD stones/debris on ERCP were identified. Patients were then divided into two groups based on amylase and lipase levels. Group 1- Acute pancreatitis patients with amylase and lipase levels 3 times the upper range of normal lab values. Group 2- No acute pancreatitis with normal amylase and lipase levels. Statistical analysis were made using Fisher’s exact test.

Results: A total of 102 Hispanic patients were identified during the study period, with 109 ERCP procedures and found to have CBD stones/debris.

Mean age was 44 (Range: 11-88yrs). 82(75.2%) of the cases were females and 27(24.8%) were males. All the patients (100%) presented with abdominal pain.

There were 42 patients in Group-1 with 42(38.5%) ERCP procedures and 60 patients in Group-2 with 67(61.5%) ERCP procedures. Prior history of cholecystectomy was present among 9/42 (21.4%) in Group-1 and 14/67 (21%) in Group-2. Further results are summarized in the following tabular form.

Statistically significant difference was found between the two groups (p value0.032). Odds ratio was 2.44 and 95% confidence interval was 1.08-5.49.

Conclusion: BMI more than 30 is a risk factor for acute pancreatitis in patients with CBD stones among Hispanic population.

Group-1 (Acute Pancreatitis) 42

Group-2 (No acute pancreatitis) 67

BMI < 30

13

35

BMI > 30

29

32

© 2011 by the American College of Gastroenterology

Purpose: Endoscopic retrograde cholangiopancreatography (ERCP) in patients with surgically altered gastroduodenal anatomy is challenging. Long length of afferent limb and altered location make selective cannulation of the hepaticojejunostomy site (HJS) difficult. Single-balloon enteroscopy (SBE) is a new modality that uses a single-balloon splinting overtube to sequentially reduce and pleat the small bowel over a standard enteroscope, and enables negotiation of acute angulations sometimes found at gastroenteric or enteroenteric anastomoses. A few case-series reported SBE assisted ERCP is promising for replacing conventional approaches, push enteroscopy or percutaneous transhepatic cholangiography (PTC). The aim of this study is to assess the efficacy and safety of SBE assisted ERCP in patients with surgically altered anatomy in a high volume tertiary referral center.

Methods: This is a retrospective cohort study. All procedures were performed by a single experienced pancreatobiliary endoscopist. Patient demographics and all the related clinical data were obtained from hospital record. Overall success rate of completion of procedure is measured as main outcome. Procedure-related complications were also assessed.

Results: Fifteen patients (5 men, 10 women) with a median age of 62 years (range 35-83 years) underwent 22 SBE procedures from March 2009 to May 2011. Surgically altered anatomy consisted of Whipple procedure with Rouxen-Y (n = 12) and hepaticojejunostomy with Roux-en-Y (n = 3). ERCPs were initially performed for obstructive jaundice (n = 10), cholangitis (n = 3), cholangitis with liver abscess (n = 1), and post-PTC internalization (n = 1). Additional procedures were conducted for post-PTC internalization after initial failure of SBE-ERCP (n = 4), stent exchange (n = 2), and biopsy for stenosis (n = 1). The HJS was reached in 15 (68.2%) of 22 procedures. Failure cases of HJS detection were complete malignant luminal occlusion (n = 2), excessive looping of endoscope (n = 4), and inability to recognize HJS (n = 1). Therapeutic ERCP was required in 11 cases in whom the HJS was reached and successfully performed in 7 cases (63.6%), including balloon dilation (n = 2), balloon dilation plus stenting (n = 2), and stenting (n = 3). The mean procedural time from scope insertion to scope withdrawal for all procedures attempted and successful interventions were 80.7 minutes (range 42-126 minutes) and 95.6 The American Journal of Gastroenterology

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minutes (range 73-126 minutes), respectively. Median follow-up was 61 days (range 30-570 days) and no procedural complications occurred.

Conclusion: SBE assisted ERCP is safe and carries an acceptable success rate in experienced hands.

160 Enhanced Expression of Connective Tissue Growth Factor (CTGF/CCN2) and Its Fibrogenic Role in Human Chronic Pancreatitis Runping Gao, MD, Yahui Liu, MD, Jie Zhu, MD, Rongli Piao, MD, Xiujun Zhang, MD, Fanghui He, MD. First Hospital, Jilin University, Changchun, China.

Purpose: Chronic pancreatitis (CP) is characterized by progressive fibrosis.

Pancreatic stellate cells (PSC) are known to play a crucial role in pancreatic fibrogenesis in CP. Our previous studies demonstrated that connective tissue growth factor (CTGF/CCN2) is a downstream mediator of TGF-β1-induced collagen I production in rat PSC and induces the cell adhesion, migration and proliferation. Here, we assessed the role of CCN2 in fibrogenesis in human CP. Methods: Pancreatic tissues from 24 patients with CP and from 6 controls with normal pancreatic histology were examined for TGF-β1 and CCN2 mRNA by in situ hybridization. CCN2 and Collagen type I protein were detected by immunohistochemistry. Computer image analysis was performed to measure the integrated optimal density (IOD) of TGF-β1, CCN2 mRNA and collagen I protein-positive cells in pancreas tissues respectively. Histological fibrosis stages were evaluated by H and E staining and Van Gieson’s method, while PSC were identified by immunochemical staining for desmin, α-SMA and FSP-1 in serial sections of pancreatic tissues.

Results: TGF-β1 mRNA was detected mostly in perilobular and periacinar PSC, acinar cells and macrophages, less often in centroacinar cells, intercalated duct and introlobular ductal epithelium. Concomitant expressions of TGF-β1 and CCN2 mRNA were seen in these areas. However, enhanced expressions of CCN2 mRNA and protein were also often found in α-SMA- and desmin-positive fibroblast-like cells around intralobular and interlobular ductal epithelium, a presumptive subtype of activated PSC. The expression and distribution of CCN2 displayed strong consistency with those of collagen I in the perilobular and introlobular areas. Computer image analysis showed that the enhanced expressions of pancreatic TGF-β1, CCN2 mRNA and collagen I protein were 4.7-, 5.9- and 7.6-fold in the patients with CP compared with the normal controls and that the content of pancreatic CCN2 was positively correlated with the content of collagen I and the enhancement of histological fibrosis staging (r = 0.89, 0.85; both p<0.05).

Conclusion: These data support the role of CCN2 in pancreatic fibrogenesis in human CP and highlight CCN2 as potential novel therapeutic targets.

161 D-Dimer as a Single Marker for Early Prediction of Severity, Necrosis, Organ Failure and Mortality in Acute Pancreatitis 2011 ACG Presidential Poster Sreekanth Appasani, MD,1 Neelam Varma, MD,2 Thakur Deen Yadav, MS,3 Savita Verma Attri, MD,4 Ragesh Babu Thandassery, MD,1 Satya Vati Rana, MD,1 Kartar Singh, MD, DM,1 Kochhar Rakesh, MD, DM, FACG1.

1. Department of Gastroenterology, Postgraduate Institute of Medical Education and Research, Chandigarh, India; 2. Department of Hematology, Postgraduate Institute of Medical Education and Research, Chandigarh, India; 3. Department of Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India; 4. Department of Biochemistry, Postgraduate Institute of Medical Education and Research, Chandigarh, India.

Purpose: To prospectively evaluate the role of serum D-Dimer (SDD) levels in determination of severity and hospital course of acute pancreatitis and correlate it with standard scoring systems.

Methods: 70 consecutive patients (64% males, age 15-76 yrs) with acute pancreatitis were studied after an informed consent. Patients were stratified into mild & severe pancreatitis as per Atlanta criteria. Serum D-Dimer (SDD) ­levels were analyzed quantitatively at admission by immune turbidity method. RANSON, The American Journal of Gastroenterology

APACHE, BISAP & MOFS scores were calculated along with CRP levels. Patients were treated with supportive care including nutritional and organ support. Antibiotics and biliary, radiological and surgical interventions were considered as per clinical requirement. SDD levels were compared with standard parameters while analyzing severity and outcome of acute pancreatitis using SPSS v17.0.

Results: The median levels of serum D-Dimer (SDD) were higher in patients with severe pancreatitis (49.75 μg/ml, n = 40) than in those with mild pancreatitis (16.50 μg/ml, n = 30, p<0.001). At a cut off of 12.10 μg/ml, SDD had a sensitivity of 95% and specificity of 97% in predicting severe pancreatitis (AUC = 0.975).

The median SDD levels were higher with higher degree of necrosis (>50% = 50.68μg/ml, 30-50% = 43.44 μg/ml, <30% = 40.14 μg/ml and those without necrosis = 20.06μg/ml, p<0.001). The median SDD levels were higher in patients with organ failure than those without (47.44 μg/ml vs 16.48 μg/ml, p<0.001).

Patients who developed fluid collections had higher SDD levels than those who did not (43.43 μg/ml vs 27.87 μg/ml, p<0.001). Patients who died had higher SDD levels than those who survived (54.93 μg/ml vs 30.64 μg/ml, p<0.001).

Correlation of SDD levels using Pearson & Spearman bivariate analysis revealed good correlation (p<0.001) with CTSI (0.512), CRP (0.505), APACHE score (0.677), RANSON score (0.565), BISAP score (0.612) and MOFS score (0.687).

Conclusion: Serum D-Dimer (SDD) level at admission is an effective predictor of severity of acute pancreatitis as well as of development of organ failure, necrosis and mortality. SDD correlated with APACHE, RANSON, BISAP & MOFS scores and serum CRP in predicting hospital course and outcome. We recommend SDD as a single marker as a predictor of severity of acute pancreatitis.

162 Up-regulation of Toll-like Receptor 4 Signaling Pathway in Human Chronic Pancreatitis Runping Gao, MD, Jie Zhu, MD, Xiujun Zhang, MD, Yahui Liu, MD, Rongli Piao, MD, Fanghui He, MD. First Hospital, Jilin University, Changchun, China.

Purpose: Bacterial endotoxin/lipopolysaccharide (LPS) is a trigger factor in the initiation and progression of alcoholic pancreatitis. The stimulation of Toll-like receptor 4 (TLR4) by LPS induces the synthesis and release of critical proinflammatory cytokines that may be related with the development and progression of multiple organ injury during acute pancreatitis. The aims of this study were to determine the expression characteristics of genes of TLR4 signaling pathway (TLR4, MyD88 and TNF-α) in human chronic pancreatitis (CP) in histology.

Methods: Pancreatic tissues from 24 patients with CP and 6 controls with normal pancreatic histology were examined for TLR4 mRNA by in situ hybridization. MyD88 and TNF-α were detected by immunohistochemistry. Computer image analysis was performed to measure the integrated optimal density (IOD) of TLR4 mRNA, MyD88 and TNF-α-positive cells in pancreas tissues, respectively. Desmin, α-SMA and FSP-1 were measured for identification of pancreatic stellate cells (PSC) in serial sections of pancreatic tissues.

Results: In situ hybridization analysis showed that a significant increase of TLR4 mRNA could be detected in most perilobular and periacinar PSC, acinar cells and macrophages, but in fewer centroacinar cells, intercalated ducts and introlobular duct epithelial cells in these patients. Concomitant expressions of TLR4 mRNA, MyD88 and TNF-α proteins were seen in these areas. Computer image analysis showed that the enhanced expressions of TLR4 mRNA, MyD88 and TNF-α proteins were 4.2-, 6.1- and 10.2-fold in these patients compared with the normal controls.

Conclusion: The critical genes of TLR4 signaling pathway are over-expressed in CP, especially in the PSC, acinar cells and macrophages. These data indicate that MyD88-dependent pathway of TLR4 signaling may play a role in the pathogenesis of CP. Table 1. The expressions of genes of TLR4 signaling pathway in human CP Groups

N

TLR4 mRNA (IOD)

MyD88 (IOD)

TNF-α (IOD)

Normal control

6

9.85±3.67

4.87±1.53

7.12±2.65

Chronic pancreatitis

24

41.84±15,26*

32.78±11.59*

72.31±22.53�� *�

*P < 0.01 vs normal control.

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163 Diagnostic Yield and Safety of Endoscopic Ultrasound Guided Fine Needle Aspiration for Solid and Cystic Pancreatic Lesions Nina Singh, MD, Matthew Clark, DO, Ryan Butterfield, MPH, Samir Habashi, MD, FACG, Ravindranath Kottoor, MD, FACG. University of Florida, Jacksonville, FL. Purpose: Endoscopic ultrasound guided fine needle aspiration (EUS-FNA) is the diagnostic and staging modality of choice for solid and cystic lesions of the pancreas. The procedure has high diagnostic accuracy with a low complication rate. We reviewed cases of EUS-FNA to assess diagnostic yield, complication rate, 30-day hospital admission rate and 30-day mortality after this procedure.

Methods: This was a single center retrospective study in which we reviewed all patients that underwent EUS-FNA for a suspected pancreatic neoplasm or pancreatic cyst on CT from August 2005-December 2009 using the electronic medical record. Patients who did not have histologic data available were excluded. Outcomes recorded included number of FNA passes, histologic findings, fluid CEA and amylase, immediate complications, 30-day hospital admission rate, 30-day mortality rate and surgical pathology findings if the patient underwent surgery.

Results: Of a total of 566 upper EUS performed, 85 patients underwent 104 EUS-FNA for solid and cystic lesions of the pancreas of which 89 specimens met inclusion criteria. All patients with cystic fluid aspiration received perioperative antibiotics. 77 cases had a positive diagnostic finding resulting in 86.5% diagnostic yield. 12 specimens were hypocellular, insufficient to make a diagnosis. 75% of these cases were with two or fewer FNA passes. Of the patients that underwent surgery, four malignant lesions were missed by EUSFNA. There were no immediate complications and overall complication rate was 1%. This one patient developed an infected cyst that responded to intravenous antibiotics. The 30-day mortality rate was 0% and 30-day admission to the hospital rate was 15%, one-third of them being for GI complaints.

Conclusion: Based on our series, EUS-FNA has a high diagnostic yield, low complication rate, and low 30-day hospital admission and mortality rate. The one complication occurred, despite prior antibiotic administration, because initially a 22-gauge needle was used to sample the lesion without success and subsequently a 19-gauge needle was used in which sufficient fluid was obtained with positive diagnostic yield. The infection was likely a result of contamination of the needle path when a second needle was introduced through the cyst wall. Based on this, to avoid infection in a cystic lesion, it is our recommendation to choose a larger caliber needle initially when evaluating a pancreatic cyst. This would result in the greatest likelihood of obtaining specimen in the first pass and minimize risk of infection from introduction of another needle.

Additionally, to avoid an insufficient specimen, it is our recommendation to perform greater than 2 passes.

group is slightly older than 2 groups p = 0.02. Albumin level in surgical group is slightly lower than other 2 groups p = 0.03. Mean WBC count is similar for all three groups p = 0.12. Treatment success rate was 74%,54%,62% in EUS, CT and surgical groups respectively p = 0.013. Treatment success rate is highest in PP located in the head and lowest in body there is no statistical difference chi = 7.37 p = .117. Success rate of tail PP drainage in EUS group was 83.3%. Reintervention rate was 36%,33%,50%, in EUS, CT, and surgery groups respectively. Complications were observed in 31%, 12% and 25% in EUS, CT and surgical groups respectively. Total length of stay was significantly different in the three groups 12, 31 and 56 days in EUS, CT and surgery groups respectively. Average cost of hospital stay for patients in EUS group $91186 was less when compared with CT groups $279393 and surgical $458455 p<0.0001.

Conclusion: This study shows reasonable success rates in all three modalities when compared to recent studies. EUS guided drainage is increasingly accepted as an initial step in management considering success rate, cost and complications obviating the need for surgery. On average, length of hospital stay and associated cost for patients who were admitted and had PP drainage is very high, which were due to multiple co-morbidities. Major study limitation is lack of stratification based on severity of condition and underlying co-morbidities. A large randomized study is needed to better evaluate and compare costs and outcomes of these three modalities.

Table 1 EUS group

CT- guided group

Total number

19

31

Surgery group 8

Male Female

10 9

15 16

53

Mean age (y)±SD

48.89±14.79

55.93±17.44

49.5±14.36

Mean psedocyst size cm±SD

10.05×9.5 cm± (6.48×5.42)

9.22×8.38± (4.67×3.51)

10.11×7.77± (4.35×3.68)

Head Body Tail More than one part

2467

5 8 4 14

1403

Etiology Idiopathc Gallstone Alcohol Surgical Medicine

31.57% 36.84% 21.05% 10.52% 0%

25.8% 48.38% 19.35% 3.22% 3.22%

25% 25 % 37.5% 0% 12.5%

mean number of co-morbidities

1.65±1.22

2.25±1.36

1.81±0.68

Mean serum albumin (g/dL)±SD

2.71±0.93a

1.91±0.63b

1.73±0.25

Mean WBC count (th/mm3)

11.02±3.81

13.81±8.22c

11.8±2.86

a: based on 18 patients b: based on 26 patients. C based on 27 patients.

Table 2

164 A Retrospective Study of Pancreatic Pseudocyst Management Pavan Manchikalapati, MD, Joan Kheder, MD, Wahid Wassef, MD,MPH, FACG. University of Massachusetts Medical School, Worcester, MA. Purpose: Pancreatic pseudocysts (PP) can be managed by surgery, EUS (endoscopic ultrasound) and CT-guided drainage. There is scant data on the clinical outcomes and the cost of these three procedures. Aim: To study the characteristics of clinical outcomes concerning EUS, Surgical and CT guided techniques of PP drainage, and associated direct cost of hospitalization.

Methods: Chart review by searching UMass Memorial Medical Center database between June 2005 and April 2011 was done for all patients with PP who had drainage. Patients were classified on basis of initial procedure. Main outcome is treatment success which was defined as complete resolution or decrease in size of PP to 2 cm, in association with clinical resolution of symptoms at 6 week follow up. Re-intervention was defined as need for repeated procedure because of persistent symptoms with a residual PP more than 4 cm. Direct cost in U.S. dollars included all charges for hospital stay from day of admission to discharge.

Results: 58 patients were identified, 19, 31 and 8 patients in EUS, CT and Surgery groups. Clinical characteristics are described in Table 1. CT guided

© 2011 by the American College of Gastroenterology

EUS group

CT- guided group

Surgery group

74%

54%

62%

Reintervention rate

36%

33.33%

50%

Complication rate

31%

12.5%

25%

12

31

56

$91186

$279393

$458455

Treatment success rate

Total length of stay mean in days Average cost

165 Large Pancreatic Cystic Neoplasms Are Not Associated with Current Biomarkers of Malignancy Linda Lee, MD, Vivek Kadiyala, MD, Shivani Mehta, PA-C, MMS, Peter Banks, MD, Darwin Conwell, MD, MS. Brigham and Women’s Hospital, Boston, MA. Purpose: Predictors of malignancy in pancreatic cystic neoplasms include symptoms, pancreatic main duct dilation, mural nodularity, and cyst size.

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Cysts ≥3 cm are believed to correlate with malignancy, and this impacts current management strategies and practice guidelines. Aim: To identify clinical, endosonographic, laboratory, and pathologic factors that are associated with pancreatic cyst size ≥3 cm or <3 cm.

Methods: This is a retrospective study performed at a Pancreas Referral Center. All subjects underwent an endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic cystic neoplasms from 6/2006 to 5/2011. Data collected include: demographics (age, gender, race), clinical features (symptoms), EUS findings (size, septations, nodularity), laboratory data (cyst fluid CEA, k-ras, LOH, cytology), and surgical pathology (malignancy defined as high-grade dysplasia, carcinoma in situ, and invasive carcinoma). Univariate and multivariate logistic regression analyses were performed on these variables to measure association and identify predictive variables (SPSS version 16.0).

Results: There were 239 patients with pancreatic cystic lesions evaluated with EUS-FNA of which 68/239 (28.5%) were ≥3 cm. Mean age was 63.7 yr with 66% (157/ 239) female and median follow-up 10 months. Evaluation of Pancreas Cyst Size: presence of symptoms (p = 0.001) and absence of k-ras mutation (p = 0.043) were associated with cysts ≥3 cm while malignant pathology was not related to cyst size (p = 0.315). For cysts ≥3 cm, 1.5% (1/68) were malignant while 4.7% (8/171) were in cysts <3 cm. Only symptoms (p = 0.008) remained significantly associated with cysts ≥3 cm in multivariate logistic regression analysis when controlling for age, gender, and race.

Conclusion: Pancreatic cystic neoplasms ≥3 cm are not associated with malignancy and k-ras mutation compared to cysts <3 cm. Larger pancreatic cysts are more likely to be symptomatic. Improved biomarkers are necessary to guide management of pancreatic cystic neoplasms regardless of cyst size.

166 Edoscopist Administered Sedation for ERCP Shortens Total Procedure Time Bingru Xie, MD, Jina Patel, MD, Xiangtian Hu, MD, Sunita Sood, MD, Dharmesh Kaswala, MD, Weizheng Wang, MD. UMDNJ, New Jersey Medical School, Newark, NJ. Purpose: Endoscopic retrograde cholangiopancreatography (ERCP) sedation include general anesthesia (GA), monitored anesthesia care (MAC), endoscopist administered conscious sedation (CS) depending on the geographic location and hospital settings. Usually it depends on the institutional habits rather than consideration for the efficacy, duration of procedure, cost and safety of procedure. Aim: To determine the difference among MAC, GA and CS in the prospects of procedure duration and complication rate.

Methods: A total of 150 consecutive patients undergoing ERCP at our endoscopy suite in a academic university hospital were reviewed. Seven patients received MAC (group1), 120 patients received GA (group 2) and 23 patients received CS (group 3). Data was recorded as age, gender, procedures (stone removal, stent placement or removal, sphincterotomy, complication as acute pancreatitis, and total procedure time. The total procedure time is defined as the time starting from giving the sedative medication and ending with extubation in patient had GA or withdrawing scope from the patient in those who had MAC or CS. The Fisher exact test was used to compare dichotomous variables. The unpaired t test was used to compare differences in the means of continuous variables. An unadjusted P value of 0.05 was used to determine statistical significance.

Results: The age, gender and procedure done during ERCP are comparable among these 3 groups with p values > 0.05 (table 1, table 2). One patient (14%) developed acute pancreatitis in group 1, whereas 7 patients (6%) in group 2 and 9 patients (9%) in group 3. The ratio of pancreatitis in these groups are not statistically different (P values>0.05, table 2). The total procedure time is 77+16 minutes in group 1, 88+48 minutes in group 2 and 52+26 minutes in group 3.

It is statistically different between group 2 and group 3, between group 1 and group 3. But it is not statistically different between groups 1 and 2.

Conclusion: CS for ERCP makes the total procedure time much shorter compared with GA or MAC. And the risks of developing acute pancreatitis, which is the most common complication after ERCP, are the same among these three groups. In summary, CS is an efficient, quick and cost effective sedation for ERCP procedure in selective patients while it has similar post-ERCP complication rate as GA and MAC. The American Journal of Gastroenterology

167 Pancreatic Cancer Resection, a Single Center Experience Dusanka Grbic, MD, Nathalie Carrier, MSc, Annie Beaudoin, MD. Gastroenterology, University of Sherbrooke, Sherbrooke, QC, Canada.

Purpose: Pancreatic cancer has a poor prognosis with surgical resection being the only available therapy offering a chance for long-term survival. Over the past 20 years, the literature has documented a dramatic decrease in the postoperative morbidity and mortality rates associated with pancreatic resections with overall 5-year survival reported up to 30%. The aim of this study is to describe our local experience.

Methods: Between 2000 and 2010, 78 patients had a pancreatic tumor resection in CHUS hospital Hôtel-Dieu and Fleurimont. We retrospectively analyzed 34 patients who had a pancreatic resection for adenocarcinoma and 44 patients who had a pancreatic resection for other pancreatic tumors. The survival was estimated with Kaplan-Meier plots.

Results: The mean age of patients was 63 years. Nine surgeons did these 78 resections. 94% of patients had an abdominal CAT scan and 53% had an endoscopic ultrasound evaluation preoperatively. Whipple procedure was performed on 61 patients, 11 had distal pancreatectomy and 6 had a total pancreatectomy. Of patients with adenocarcinoma, 62% had an R0 resection and 57% had regional lymph node metastasis on pathological examination. Postoperative 60-day mortality for all patients was 7.7% (6/78). Significant postoperative morbidity was observed in 60% of patients and 9% had a pancreatic fistula.

Their median hospital stay was 26 days. Of patients with adenocarcinoma, 43% had adjuvant chemotherapy and 23% had adjuvant radiotherapy as well. The patients median survival for all tumors was 30 months and of 12.5 months for patients with pancreatic adenocarcinoma. Their 5-year survival was estimated to 44% for all tumors and 15% for the pancreatic adenocarcinoma.

Conclusion: In order to improve our long-term survival, we must improve our preoperative evaluation to better identify patients with positive lymph nodes.

We should reduce number of surgeons performing pancreatectomies in order to achieve more R0 resections and lower postoperative morbidity and mortality. Those strategies will hopefully allow more patients to be eligible for adjuvant therapies and improve overall survival.

168 The Role of Probe Based Confocal Endomicroscopy in the Determination of Indeterminate Biliary Strictures Mohamed Othman, MD, Sergio Crespo, MD, Bashar Qumseya, MD, Muhammad Shahid, MD, Muhammad Hassan, MD, Chakri Panjala, MD, David Loeb, MD, Stephen Lange, MD, Michael Wallace, MD, MPH. Internal Medicine/Gastroenteroloy, Mayo Clinic, Jacksonville, FL. Purpose: Despite recent advances in biliary imaging and biliary tissue acquisition, the diagnosis and tissue-confirmation in suspected malignant biliary Volume 106 | supplement 2

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obstruction remains challenging. Single-operator cholangioscopy and confocal endomicroscopy (pCLE) are recent advances that may increase the diagnostic yield of malignant strictures. We evaluated the role of cholangioscopic and fluoroscopic guided pCLE imaging of biliary strictures during ERCP. Methods: All enrolled patients underwent initial ERCP fluoroscopic documentation of the stricture. One half ml of 10% fluorescein was given IV, and continuous pCLE images were obtained for 3 minutes. Fluoroscopic guided pCLE was performed at the site of maximal duct narrowing. This was immediately followed by cholangioscopic guided pCLE imaging of the most suspicious site on direct cholangioscopy. Standard brush cytology was performed, followed biopsies. Malignancy was defined by any positive cytology, FISH, or biopsy. PCLE images were de-identified and reviewed by 4 physicians blinded to the final diagnosis and method of imaging. Images were assessed for quality and level of confidence of diagnosis, and the presence of features consistent with malignant strictures using the Mia. Results: Nine patients were enrolled from 5/2009 through 11/2010 (5 men and 4 women). The median age at time of procedure was 57 yrs (35-71). The majority of patients were Caucasian (one African American). Four patients had malignant strictures. Overall accuracy for pCLE imaging for benign or malignant strictures was 60% for fluoroscopic guidance, and 70% for cholangioscopic guidance. pCLE correctly identified malignant strictures (sensitivity) in 25% of cases under fluoroscopic guidance and 75% of cases under cholangioscopic guidance. More than 80% of the pCLE images were rated as moderate or best quality with no significant difference between fluoroscopic and cholangioscopic guided images. Seventy nine percent of fluoroscopic guided pCLE images were rated with moderate to high diagnostic confidence, whereas 90% of cholangioscope guided pCLE images were rated moderate to high (p = 0.35).

Conclusion: Diagnosis and tissue-confirmation in suspected malignant biliary obstruction remains challenging. Cholangioscopic directed biopsies may have a role in determining malignant biliary strictures. This preliminary study suggests that pCLE imaging may provide an additional accurate imaging modality in the diagnosis of malignant biliary strictures, particularly under cholangioscopic guidance.

169 Is It Safe to Follow Cystic Pancreatic Neoplasms if Immediate Surgery Is Not Undertaken?

Muslim Atiq, MD, Jeffrey Lee, MD, William Ross, MD, Brian Weston, MD, John Stroehlein, MD, Gottumukkala Raju, MD, Manoop Bhutani, MD. Gastroenterology, Hepatology and Nutrition, UT MD Anderson Cancer Center, Houston, TX. Purpose: To characterize clinical outcomes and follow up in patients with pancreatic cystic neoplasms not undergoing surgical intervention.

Methods: We searched our endoscopy database for data and included patients with pancreatic cysts between January 2005 and December 2009 with at least 12 months of clinical follow up. Inclusion criteria: Mucinous cystic neoplasms, side branch IPMN including those with Pancreatic Duct (PD) <6 mm without features of main duct IPMN, serous cystadenoma based on clinical, radiological and EUS-FNA features. Exclusion criteria: Main duct IPMN, pancreatic pseudocyst, mesenteric cysts, and pancreatic cysts that underwent surgical resection. Data on demographics, clinical presentation, CT findings at presentation and at follow up, EUS features, cyst fluid analysis, as well as clinical and radiological follow up were collected.

Results: 49 patients were identified. Mean age was 68.6+/-10.9 years. 30 (61.2%) were females. Presentation included an incidental finding in 36 (73.5%), abdominal pain in 10 (20.4%) and weight loss in 3 (6.1%) patients. A solitary lesion was seen in 33 (67.3%) patients. Median size of largest cystic lesion on CT and EUS at initial presentation was 23.5 +/- 18.0 mm and 21.5 +/- 14.3 mm respectively. Locations included head in 19 (38.8%), body in 16 (32.7%), tail in 6 (12.2%), neck in 5 (10.2%), uncinate in 3 (6.1%) patients. Septae were seen in 12/49 (24.5%) patients. Other EUS findings included wall thickness in 5/49 (10.2%), intracystic component in 6/49 (12.2%), PD dilatation in 8 (16.3%) © 2011 by the American College of Gastroenterology

and possible cyst communication with PD in 11 (22.4%) of patients. Fluid was reportedly viscous in 17/49 (34.7%) aspirations. Mucin was seen on histopathology in 14 (28.6%) patients. Cyst CEA levels were available in 35/49 (71.4%) patients. In these 35 patients, cyst CEA level <192 ng/mL was seen in 28 (80%) and >192 ng/mL in 7 (20%) patients. A follow up CT study was available in 46/49 (93.9%) patients after a median follow up of 24.8+/-18.4 months. On follow up, cyst were seen to have regressed in size in 15 (30.6%), remained stable in size in 7 (14.3%) and increased in size in 22 (44.9%) patients. Among these 22 patients, median increase in cyst size was 5.1+/- 7.8 mm. 46/49 (93.9%) patients were alive with a median follow up of 25.5+/-15.3 months without any clinical or radiological evidence of invasive malignancy.

Conclusion: Most cystic lesions of pancreas are found incidentally. It appears to be reasonably safe to follow pancreatic cysts for up to two years, including those considered to be mucinous but without overt malignancy that are not operated on for one reason or another.

170 The New Rendezvous Techniques with KPM Catheter for Treatment of Biliary Stricture after Right-lobe Living Donor Liver Transplantation: Feasibility Study Inseok Lee, MD, Jae Hyuck Jang, MD, Si Hyun Bae, MD, Jong Young Choi, MD, Seung Kew Yoon, MD, Dong Goo Kim, MD, Young Kyung You, MD, Ho Jong Chun, MD, Byung Gil Choi, MD, Hae Giu Lee, MD, Sang Woo Kim, MD, Myung-Gyu Choi, MD, In-sik Chung, MD, Yu Kyung Cho, MD, Jae Myung Park, MD. The Catholic University, Medical College, Seoul, Republic of Korea.

Purpose: Endoscopic treatment is the first choice in the biliary stricture after right-lobe living donor liver transplantation (LDLT) but has a risk of failure.

The rendezvous technique is alternative and useful modality to insert stent inside the stricture. We studied the feasibility and safeness of the new rendezvous method with 5 Fr KPM catheter.

Methods: Patients with biliary stricture after LDLT were underwent percutaneous transhepatic biliary drainage (PTBD) and then changed to 5Fr KPM catheter for rendezvous ERBD insertion. All patients were send to ERCP room for insertion of internal stent. We retrospectively analysed the medical record. The primary endpoint were procedure time and success rate and compared usefulness of KPM catheter rendezvous technique to previous reported data.

Results: Twelve patients were included in this study from April to December, 2010. Median procedure time was 14 min (range 5-55) and more faster than guidewire rendezvous technique (median 29.4 min, 7.5-76.7)(P = 0.007).

All procedures were successful. The number of internal stent was one in 10 patients and two in 2 patients. Mean diameter of internal stent was 9.8 Fr. All procedure were under the duodenoscope. There was no significant procedure related complication.

Conclusion: Rendezvous technique with KPM PTBD catheter was safe and faster than previous technique. We suggest this technique as a one of alternative modality for a patients who are failed of initial endoscopic intervention.

171 Correlation Between the Prevalence of Gallstone and Helicobacter pylori infection Beom Jin Kim, MD, PhD,1 Jae Gyu Kim, MD, PhD,1 Sang-Jung Kim, MD,2 Sung Chul Choi, MD3. 1. Internal Medicine, Chung-Ang University Hospital, ChungAng University College of Medicine, Seoul, Republic of Korea; 2. Boondang Jaesaeng General Hospital, Gyungki-do(province), Republic of Korea; 3.

Samsung Medical Center, Sungkyunkwan University College of Medicine, Seoul, Republic of Korea.

Purpose: Several studies have been reported that the presence of ­Helicobacter DNA in human bile sample, although its pathological role is not clear.

Moreover, little is known about the association between Helicobacter pylori (H. pylori) infection and gallstone. The aim of this study was to determine whether H. pylori infection is associated with an increased risk of gallstone in asymptomatic population.

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Methods: We examined 2782 subjects (1635 men and 1147 women) who underwent both upper endoscopy with CLO test and abdominal ultrasound at the Health Examination Center at Chung-Ang University Yong-san Hospital in Korea from January 2007 to December 2009. We compared the prevalence of gallstone on ultrasound and endoscopic findings such as reflux esophagitis, gastric diseases in the H. pylori infected subjects with that of the H. pylori uninfected subjects.

Results: The overall prevalence of H. pylori infection in our study was 45.6% (1271/2782). When the subjects were divided into two groups according to the H. pylori infection status, there was no significant differences of the baseline characteristics between the two groups. The prevalence of gallstone in the H. pylori infected subjects was higher than that of the H. pylori uninfected subjects (5.4% vs 3.2%, P = 0.032). The prevalence of peptic ulcer in the H. pylori infected subjects was higher than that of the <i.H. pylori,/i> uninfected subjects (8.2% vs 3.4%, P<0.001). The prevalence of reflux esophagitis in the H. pylori infected subjects was lower than that of the H. pylori uninfected subjects (6.2% vs 14.0%, P = 0.012).

Conclusion: These findings suggest that H. pylori infection is associated with an increased risk of gallstone in asymptomatic population.

172 The Role of Positron Emission Tomography (PET) in Addition to Computed Tomography (CT) in the Staging of Pancreatic Adenocarcinoma Vanessa Costilla, MD, Mitesh Borad, MD, Nancy Han, MD, Michael Crowell, PhD, Douglas Faigel, MD, FACG, Rahul Pannala, MD, FACG, Laurence Miller, MD, Cuong Nguyen, MD, FACG, Alvin Silva, MD, Joseph Collins, MD, Adyr Moss, MD, Jonathan Ashman, MD, G. Anton Decker, MD, FACG. Mayo Clinic Arizona, Scottsdale, AZ. Purpose: PET has been advocated in the staging of pancreatic adenocarcinoma, but is expensive and not universally available. We sought to determine if PET detects additional metastases when compared to CT abdomen and chest in patients with biopsy proven pancreatic adenocarcinoma.

Methods: Patients with biopsy-proven pancreatic adenocarcinoma at Mayo Clinic Arizona between 2002 and 2010 were identified. Initial TNM staging (AJCC Cancer Staging Manuel, Seventh Ed.) was by CT abdomen and CT chest. PET was performed within three months, irrespective of CT stage.

Detection of metastases by CT vs.PET was compared using McNemar’s test for agreement. Results are reported as mean + SD. Results: 44 patients (43% men, mean age 72.7 ± 9.1) met entry criteria. Staging was similar between CT abdomen/chest and PET in 34/44 cases (p = 0.75).

There were 10 discordant cases. Four cases where CT stage was 4 but PET was not (Table 1), six cases where PET was stage IV but CT was not. The addition of PET resulted in upstaging to stage IV in 6/44 (13.6%) cases (Table 2); two of these patients were upstaged from resectable disease on CT, thereby preventing unnecessary surgery. Confirmatory biopsies of the lesions seen on PET were done in two of the six patients who were upstaged. PET was falsely positive in one patient and falsely negative in one patient. In 26 patients with metastatic disease on CT and PET, PET identified additional metastases in six patients Table 1. Discordant Cases: CT stage=IV, PET stage < IV (N=4)

Age

Sex

PET Stage

Pre-Surgical Confirmatory Biopsy of Metastasis

Details

Outcome

66

Female

III

No

Liver lesions seen on CT scan had no uptake on PET.

Chemotherapy

71

Female

IIA

No

Lung and liver lesions had low uptake on PET. Uptake too low to diagnose metastaticdisease.

Metastatic disease confirmed intraoperatively. False negative PET.

Surgery, chemotherapy & radiation.

66

Female

III

No

Liver lesions seen on CT scan had no uptake on PET.

Chemotherapy

70

Male

III

No

Subcentimeter liver lesions seen on CT scan had no uptake on PET.

Palliative

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Table 2. Discordant Cases: PET stage=IV, CT stage < IV (N=6)

CT Stage

Pre-Surgical Confirmatory Biopsy of Metastasis

Age

Sex

Details

Outcome

63

Male

III

Yes

70

Male

IIB

Yes

1 cm liver lesion found with PET

Chemotherapy

74

Male

IB

No

Increased uptake in porta hepatis.

Whipple performed, intraoperative staging IIB. False positive PET.

Surgery

92

Female

III

No

Bone and mesentery metastasis found with PET.

Chemotherapy

73

Female

III

No

Gallbladder, multiple portal lymph nodes and splenic involvement found with PET.

Chemotherapy & radiation

72

Female

III

No

Adrenal gland, paraortic and cervical lymph node metastasis found with PET.

Chemotherapy & radiation

Liver cysts per CT scan, found to be Chemotherapy metastatic per PET.

(23.1%). Of the 36 patients with stage IV disease by either PET or CT, 16 had confirmatory biopsies of metastases. In the remaining 20 cases biopsies of the metastases were not performed.

Conclusion: PET may be complementary to CT in the staging of pancreatic adenocarcinoma by identifying new or additional metastatic disease. By identifying additional baseline metastases, PET may allow for more accurate assessment of response to treatment. Further studies are required to determine the true sensitive and specificity of PET in detecting metastatic disease.

173 Protein C Inhibitor (Serpin A5) in ePFT Collected Pancreas fluid: A Potential Biomarker of Chronic Pancreatitis (CP) Darwin Conwell, MD, MS, Joao Paulo, PhD, Linda Lee, MD, Vivek Kadiyala, MD, Peter Banks, MD, FACG, Hanno Steen, PhD. Brigham and Women’s Hospital, Brookline, MA. Purpose: To characterize differential protein expression profiles using proteomic analysis of pancreas fluid (PF) from patients with severe CP and controls.

Methods: PF was collected from two cohorts (CP and controls) using the ePFT method and subjected to comprehensive proteomic analysis (GeLC-MS/MS) and protein identification as follows: PF was collected from the duodenum after secretin stimulation (ChiRhoStim); centrifuged to remove particulate matter; proteins precipitated, subjected to SDS-PAGE fractionation; followed

by In-gel tryptic digestion and proteomic analysis. Bioinformatic analysis was performed to determine protein identification and molecular function. Statistical analysis was performed with QSPEC statistical software comparing spectral counts of proteins using Bayesian statistical methods. Protein filtering strategy: A Bayes factor greater than 10 and a greater than 2-fold difference in protein expression between cohorts was statistically significant (p< 0.05).

Fisher exact test for measure of association.

Results: A total of 18 subjects (9 CP and 9 controls) underwent secretin stimulated, ePFT PF collection and proteomic analysis (GeLC-MS/MS) based on our previously published sample handling and methods protocols. All CP patients had severe CP (Cambridge Class IV imaging, EUS score 6-9). All controls had chronic dyspepsia with no evidence of CP (Cambridge Class 0 imaging, EUS score 0-3). The mean peak [HC03] for CP and controls was 37.7 ± 13.3 versus 93.4 ± 13.6 mEq/L. ( p < 0.05). GeLC-MS/MS analysis revealed the largest dataset of non-redundant proteins (n = 1392) from human PF to date. Protein filtering strategy revealed several statistically significant (Bayes factor >10; fold change >2) up-regulated proteins [serpin A5, neprilysin, mucin 13, annexin A5 and defensin 5] and down-regulated proteins [trypsin, chymotrypsin, lipase and aminopeptidase]. Biological function analysis revealed that the highest percentage of down-regulated proteins were protease enzymes. The highest percentage of up-regulated proteins were protein binding. Protein C Inhibitor [Serpin A5, table]; a serine protease inhibitor / “binder” was the top-hit protein in 8/9 CP and 0/9 control PF samples (p = 0.00041): Sensitivity (89%), Volume 106 | supplement 2

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Specificity (100%), PPV (100%), NPV (90%) and diagnostic accuracy of 94.4% [74.2, 99.0].

Conclusion: 1) Protein C Inhibitor (Serpin A5) is up-regulated and proteases are down-regulated in pancreas fluid of patients with severe chronic pancreatitis compared to controls. 2) Protein C Inhibitor expression in PF may serve as a diagnostic biomarker for chronic pancreatitis. Clinical Implication: Further investigation of Serpin A5 in milder forms of chronic pancreatitis is warranted.

174 Serum Amylase and Lipase Level and Trend Does Not Correlate with Acute Pancreatitis (AP) Severity Markers Jordan Holmes, MD, Amit Bhatt, MD, Rocio Lopez, MS, MPH, Tyler Stevens, MD. Cleveland Clinic Foundation, Cleveland, OH. Purpose: The value of serial monitoring of serum amylase and lipase in patients with AP is uncertain. We sought to determine if amylase and lipase correlate with other well-established severity indicators.

Methods: A retrospective cohort study was done. Consecutive pts with AP admitted through the Cleveland Clinic ED between January 2008 and May 2010 were included. Clinical and laboratory data at admission, 24 hrs, and 48 hrs were obtained. Outcomes included elevated BUN (≥ 20 ), BISAP score ≥ 2 , and presence of SIRS. ROC analysis was performed to assess the ability of amylase and lipase to predict these outcomes.

Results: Of 216 pts, 120 had ≥2 amylase and lipase levels drawn during the first 72 hrs. 19 pts (15.8%) had a rise in the lipase and/or amylase. Patients presenting more than two days after symptom onset had significantly lower initial amylase and lipase levels. Adjusting for the duration of symptoms at presentation, serum amylase and lipase levels and trends were poor predictors of BUN (≥ 20 ), BISAP score ≥ 2 , and presence of SIRS [ROC AUC ≤ 0.70, see table].

Conclusion: Neither the level nor the trend of serum amylase and lipase during the first 72 hours predict the presence of elevated BUN or BISAP score, or SIRS. Clinical implication: Serial measurement of serum amylase and lipase has limited clinical value.

Predictive ability of lipase and amylase adjusting for time since symptom onset

Outcome

Lipase Day 1

Change in Lipase (day 1-2)

Amylase Day 1

Change in Amylase (day 1-2)

SIRS Day 1

0.55 (0.42, 0.69)

0.55(0.42, 0.68)

0.59 (0.46, 0.72)

0.60 (0.47, 0.73)

SIRS Day 2

0.57 (0.41, 0.73)

0.57 (0.41, 0.73)

0.57 (0.41, 0.73)

0.57 (0.41, 0.73)

SIRS for 2 + days

0.61 (0.45, 0.76)

0.61 (0.45, 0.77)

0.60 (0.44, 0.76)

0.61 (0.45, 0.76)

Abnormal BUN 0.70 (0.59, 0.81) admission

0.69 (0.58, 0.80)

0.70 (0.59, 0.80)

0.68 (0.56, 0.80)

Abnormal BUN 48 hr

0.62 (0.42, 0.82)

0.63 (0.43, 0.82)

0.56 (0.38, 0.73)

0.62 (0.44, 0.80)

Day 1 BISAP 2

0.51 (0.37, 0.65)

0.51 (0.37, 0.65)

0.53 (0.39, 0.67)

0.54 (0.37, 0.70)

Day 3 BISAP 2

0.54 (0.35, 0.73)

0.51 (0.31, 0.71)

0.54 (0.34, 0.75)

0.54 (0.31, 0.77)

AUC: area under ROC curve. DeLong’s method was used to compare the AUC’s for day 1 to day 2.

175 Risk Factors for Developing Cholangitis Following Biliary Stenting for Non-Malignant Bile Duct Strictures Matthew Nikoloff, MD, Nake Pooran, MD. Penn State Milton S. Hershey Medical Center, Hershey, PA. Purpose: To determine potential risk factors for cholangitis in patients undergoing ERCP and common bile duct (CBD) stenting for non-malignant biliary strictures.

Methods: A retrospective review of all patients undergoing ERCP from August 2007-July 2009 was conducted to identify those that had a stent placed for a non-malignant biliary stricture. Patients were excluded if a biliary stent was © 2011 by the American College of Gastroenterology

already present or if there was a known malignant stricture. Demographic information, indication for ERCP, findings at ERCP, type of stent, pre-procedure antibiotic usage, and outcomes, including days of hospitalization and antibiotic duration if cholangitis developed, were recorded. The data was analyzed to determine risk of cholangitis for variables including age, sex, pre-procedure antibiotic usage, stricture location, presence of stones, and stent size. A multivariate analysis was also performed to determine statistical significance.

Results: A total of 125 biliary stents were placed. The male-to-female ratio was 0.9:1 (59M, 66F). The average age was 63.2 years. Eleven (8.8%) patients developed cholangitis before the stent was scheduled to be removed or exchanged.

Eight females (72.7%) and 3 males (27.3%) (OR = 2.51, p = 0.19) developed cholangitis. The average time to develop cholangitis was 79.9 days, resulting in 13.5 days of antibiotics and an average hospitalization of 5.3 days. Age was not a factor (p = 0.95) to develop cholangitis. Seventy-one patients received antibiotics at the time of ERCP, 8 (11.3%) of whom developed cholangitis (OR = 2.31, p = 0.23). Eleven (8.8%) patients also had a CBD stone and only 1 (9.1%) developed cholangitis (OR = 1.00, p = 1.00). Strictures in the mid or proximal CBD were found in 31 patients (24.8%) while 94 (75.2%) had a distal stricture.

Proximal strictures carried an OR = 2.40 (p = 0.19) in developing cholangitis.

Of those who developed cholangitis, 10 (90.9%) had a 10-Fr stent and 1 (9.1%) had a 7-Fr stent. On multivariate analysis, presence of a stone (p = 0.95), use of pre-procedure antibiotics (p = 0.30), and location of stricture (p = 0.19) were not found to be significant.

Conclusion: Age, sex, stent size, use of pre-procedure antibiotics, and concurrent stone are not associated with developing cholangitis after CBD stent placement.

However, female sex, use of pre-procedure antibiotics, and non-distal CBD strictures did show a trend towards cholangitis risk. A larger study addressing these factors will be needed to assess if these trends carry statistical significance.

176 An Initial Experience with the Use of Self-Expanding Metal Stents For Management of Organizing Pancreatic Necrosis David Loren, MD, Shih-Kuang S. Hong, MD. Thomas Jefferson University, Philadelphia, PA. Purpose: Recent data demonstrate that minimally invasive approaches to the management of organizing pancreatic necrosis result in decreased morbidity and mortality compared to surgical treatment. The increasing use of endoscopic necrosectomy necessitates access for therapeutic endoscopes to debride necrotic collections. There have been isolated reports of the use of self expanding metal stents (SEMS) for the purpose of facilitating access for necrosectomy.

The purpose of this study is to report an initial experience with the use of self expanding metal stents (SEMS) for the management of pancreatic necrosis.

Methods: Single center retrospective review of patients undergoing the endoscopic management of pancreatic necrosis in whom metal stents were used.

Patients were identified by query of the endoscopic along with data from medical records and review of imaging studies.

Results: Ten procedures were performed in 3 male patients, mean age = 60, for management of organizing pancreatic necrosis. The etiology was biliary pancreatitis in 2 patients and idiopathic in 1. Mean time from onset of pancreatitis to initial drainage was 12.3 weeks (range 6-25). Size of the collections ranged in long axis from 10-21 cm (mean = 17) and short axis 7-15 cm (mean = 10.7).

Mean number of procedures per patient was 3.3, over an average of 12 weeks of follow-up (range 4-22). Access to the collection in all patients was transgastric.

In 2 patients initial drainage with plastic double pigtail stents was performed, followed by SEMS, and in one SEMS placement occurred at the the first procedure. SEMS placement was successful in 9/10 (90%) of cases, with one failure of esophageal stent placement. 9 fully covered stents were placed: 5 biliary and 4 esophageal; (Wallflex, Boston Scientific, Natick MA). No stent related complications occurred at the time of placement. To facilitate necrosectomy, stent removal and replacement was performed in 80% of procedures, with two procedures performed through existing esophageal stents. All stents were removed easily without complication using either snare or grasping forceps.There were no stent migrations during the study period. There was one complication on followup with infection of satellite collections requiring ­percutaneous drainage. One patient achieved complete resolution of the collection during the study period.

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Conclusion: The use of endoscopic SEMS in the management of organizing pancreatic necrosis appears to be feasible and safe and facilitates access to collections to perform endosocopic necrosectomy. Further study of this technique is required to refine the approach and determine the clinical and technical parameters to optimize therapy.

Disclosure: Dr. Loren - Consultant, Boston Scientific.

177 Anomalous Pancreaticobiliary Junction in a Western Population Undergoing ERCP Emily Rolfsmeyer, MD,1 David Lo, MD,1 Kartik Pandya, MD,2 Dougald MacGillivray, MD,2 Andreas Stefan, MD, FACG,1 Douglas Howell, MD, FACG1.

1. Gastroenterology, Maine Medical Center, Portland, ME; 2. Maine Medical Center - Department of Surgery, Portland, ME. Purpose: Anomalous pancreaticobiliary junction (APBJ) is a rare union of the biliary and pancreatic ducts (PD), which is associated with pancreaticobiliary malignancy (PBM). We characterize our experience with this condition in a Western population.

Methods: We retrospectively reviewed an ERCP database of 7467 pts at Maine Medical Center from January 1991-February 2011. Clinical, surgical and pathological data was reviewed.

Results: APBJ was found in 26 pts (F:18, M:8, median age 48 yrs, range 4-71 yrs, 23 Caucasians, 1 African-American, 1 Hispanic, 1 Asian, 0.35% incidence in ERCP over 20 yrs). 7 pts had type I union, 17 pts had type II union. Type I choledochal cyst (CC) was present in 19 pts. 22 pts presented with abdominal pain, 5 with jaundice, 14 with acute pancreatitis (AP), and 3 with chronic pancreatitis (CP). The average time of onset of symptoms to diagnosis (dx) was 15.8 mos (range 0-78 mos). Pancreas divisum was found in 4/26 pts (complete n = 2, incomplete n = 2). Sphincterotomy (ES) was performed in 22 pts. CBD stones were extracted from 5 pts. Of pts presenting with pancreatitis, ES was performed in 14/14 with resolution of AP in 100%. Of 5 pts with recurrent AP, 2 resulted from proteinaceous debris in remnant CC stumps, 1 had pancreas divisum, 1 had chronic pancreatitis with PD stricture, and 1 had not undergone prior ES. PBM was present in 5 pts (gallbladder cancer n = 1, stage I; cholangiocarcinoma (CCa) n = 4, 3 stage IV, 1 stage II). Of the 4 pts with CCa, 2 pts who had prior biliary surgery during childhood presented with stage IV disease (1 with choledochoduodenostomy and partial CC resection 59 yrs prior to dx, 1 with cholecystojejunostomy without CC resection 48 yrs prior). 2/5 pts with jaundice presented with PBM. 17 pts underwent cholecystectomy. Of the 19 pts with type I CC, 14 pts underwent CC resection (10/14 with complete resection through the pancreatic head). 7/10 pts with complete CC resection had preoperative PD stent placed which assisted with CC dissection through the pancreatic head. Excluding the pts with biliary surgery during childhood, no surgical patients developed PBM (average follow up 3.8 yrs, range 0-16.6 yrs).

Conclusion: APBJ is rare in a Western population. Definitive therapy for recurrent AP involves ES, and potentially full CC resection. Avoidance of PBM necessitates resection of biliary mucosa, including gallbladder and choledochus. Preoperative PD stenting appears to assist with complete CC resection.

178 Performance Characteristics of Molecular (DNA) Analysis of Pancreatic Cyst Fluid Christen Klochan, MD, John DeWitt, MD, Christian Schmidt, MD, PhD, MBA, Stuart Sherman, MD, Julia LeBlanc, MD, MPH, Lee McHenry, MD, Gregory Cote, MD, MS, Jennifer Stuart, BS, Mohammad Al-Haddad, MD. Gastroenterology, Indiana University, Indianapolis, IN. Purpose: Accurate diagnosis of mucinous pancreatic cysts (MPCs) can be challenging. We aimed to prospectively evaluate the performance characteristics of cytopathology, cyst fluid tumor markers (CEA) and molecular (DNA) analysis to differentiate mucinous (MPCs) from non-mucinous pancreatic cysts.

Methods: In consecutive patients referred for EUS-FNA of pancreatic cysts, cyst fluid was aspirated for cytology, DNA analysis (RedPath®, Pittsburgh, PA) and CEA when quantity was sufficient. Criteria for MPCs: were called The American Journal of Gastroenterology

­ ucinous if 1) CEA level was >192 ng/mL; 2) FNA revealed mucinous epim thelial cells or intracellular mucin, atypical cells, or malignancy. In the DNA panel, mucinous lesions were diagnosed by DNA quantity ≥40 ng/ul and/or kras mutation and/or allelic imbalance mutation. DNA panel criteria for malignant cysts required DNA quantity≥40 ng/ul and k-ras-mutation and at least two allelic imbalance mutations. Cytopathology, CEA and DNA analysis were compared with surgical pathology in patients who underwent surgical resection and performance characteristics were calculated.

Results: Between March 2008 and April 2011, 270 patients underwent EUS-FNA of suspected MPCs with available DNA analysis. MPCs were identified in 115 cases (42.6%) by CEA/FNA, 109 (40.4%) by DNA and 59 (21.9%) by both CEA and DNA. DNA analysis identified an additional 50/270 (19%) as MPCs that were not considered MPCs by CEA and/or cytology. Of these, 7 (14%) underwent surgery showing IPMN (6) and SCA (1). Pancreatic resection was performed in 38/270 (14%) and showed: IPMN in 26 (19 with LGD, 3 with HGD, and 2 with invasive carcinoma), MCN in 3 (HGD in 1) and SCA in 1. The two cysts identified as malignant by DNA analysis were confirmed as malignant by surgical pathology (n = 1) or did not undergo resection (n = 1). The performance of each pre-operative diagnostic test in diagnosing mucinous cysts is summarized in Table 1. When the DNA panel was compared to surgical pathology, the panel was 16.7% sensitive and 100% specific in predicting malignant cysts (n = 38).

Conclusion: Using the combination of CEA, FNA and DNA analysis of pancreatic cysts increases the sensitivity for diagnosing MPCs. The DNA panel is highly specific but poorly sensitive in diagnosing malignant cysts. Additional studies are needed to define the role of DNA analysis in the management algorithm of MPCs. Disclosure: Dr. DeWitt - Received grant money from RedPath. No other authors have any relevant financial relationships.

Table 1. Performance characteristics in diagnosis of mucinous cysts Test

Gold standard used

n

Se (%)

Sp (%)

CEA

Surgical pathology

38

54.5

80

Kras

CEA & cytopathology

270

27.7

65.5

DNA

CEA & cytopathology

270

51.7

68.8

DNA

Surgical pathology

38

45.5

80

CEA, Kras, DNA

Surgical pathology

38

75

66.7

Disclosure - Dr DeWitt - Received grant money from RedPath. No other authors have any relevant financial relationships.

179 ERCP in Obese Patients: A Retrospective Analysis of Efficacy and Safety Ariyo Ihimoyan, MD, Vamshidhar Vootla, MD, Ajit Lale, MD, Nirisha Kalakada, MD, Harathi Yandrapu, MD, Anil Dev, MD, Sridhar Chilimuri, MD. Medicine, Bronx-Lebanon Hospital, Bronx, NY. Purpose: Endoscopic retrograde cholangiopancreatography (ERCP) is a widely used diagnostic and therapeutic procedure in the management of pancreato-biliary diseases. It is well documented that the incidence of gallstone disease is increased in obese patients hence an increased demand for ERCP in this patient population. The aim of this study is to compare the efficacy and safety of ERCP in obese patients versus non-obese patients.

Methods: We retrospectively reviewed all consecutive ERCP cases performed in Bronx-Lebanon Hospital from January 2007-November 2010. We sequentially compared the endoscopic records of obese patients (BMI ≥ 30) and nonobese patients (BMI < 30) in the study period. The primary outcome measures were indications, cannulation success rate, ERCP findings, interventions, periprocedure respiratory or cardiac complications and post-ERCP complications.

Results: A total of 220 ERCP procedures were performed out of which 76 cases were performed in obese patients compared to 144 in non-obese patients. The mean age was 48.4 in the obese group and 42.1 in the non-obese group while the mean BMI was 36.8 and 25.3 in obese and non-obese patients respectively.

The cannulation success rate was lower in the obese patients (81.5% vs 94% P = 0.01). The most common indication for ERCP was suspected CBD stones Volume 106 | supplement 2

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in both groups (82% in obese patients vs 66% in non-obese patients). Peri-procedure cardiac or respiratory complications were similar in both groups and post-procedure complications including pancreatitis (6.5% vs 7.6% P = 0.809), perforation (1.32% vs 0% P = 0.782) and bleeding (0% vs 2.1% P = 0.463) were not significantly different in the obese group versus the non-obese group.

Conclusion: Obese patients carry similar risks of post-ERCP complications and peri-procedure cardiac or respiratory complications as non-obese patients.

However, the cannulation success rate was lower in this group of patients compared to non-obese patients.

180 Clinical Utility of the Sendai Consensus Guidelines to Identify High Risk IPMN Megha Kothari, MD,1 Samir Kapadia, MD,2 Jeffery Lewis, MD,3 Jonathan Buscaglia, MD,2 Michelle Kim, MD,3 David Robbins, MD1. 1. Lenox Hill Hospital, Jersey City, NJ; 2. Stony Brook Hospital, Long Island, NY; 3. Mount Sinai Medical Center, New York City, NY. Purpose: Intraductal papillary mucinous neoplasms (IPMN) are unique cystic lesions which are categorized as branch duct-IPMN (BD-IPMN), main-duct IPMN (MD-IPMN), or mixed type-IPMN (MT-IPMN). In 2006, the Sendai Consensus Guidelines were created to guide surgical management of IPMNs. The guidelines recommend surgical resection of all IPMNs > 3 cm irrespective of symptoms and for all IPMNs < 3 cm with worrisome features (i.e. mural nodule or main pancreatic duct (PD) >6mm). Since BD-IPMNs have a lower lifetime risk of malignancy, compared to MD-IPMNs and MT-IPMNs, more careful selection of patients for radical surgery is a key clinical dilemma. The aim of this multi-institutional study is to evaluate the clinical utility and performance characteristics of the Sendai Consensus Guidelines (cyst size >3 cm, presence of intramural nodules, and PD diameter >6 mm) when applied to resected, pathologically confirmed BD-IPMN lesions.

Methods: We performed a retrospective review of all BD-IPMN cases between 2000 and 2010 at Lenox Hill, Stony Brook University, and Mount Sinai Hospitals. All surgical pathology and radiological reports were reviewed to extract: size (>3 cm or <3 cm), degree of dysplasia/carcinoma (low-risk lesions: mildmoderate grade, high-risk lesions: high grade/CIS/adenocarcinoma), presence of intramural nodules, and PD size on imaging.

Results: Among 63 patients (F = 38, M = 25) with confirmed IPMN between 2000 and 2010, 17 were BD-IPMN, 15 were MD-IPMN, 10 were MT-IPMN, and 21 were not further classified. Imaging reports were available on 17 BD-IPMN cases.

By the guidelines, 8 of 17 BD-IPMNs would have been recommended for surgical resection: 6 were >3 cm, 1 had a PD diameter >6 mm, and 2 had intramural nodules. Among these 8 cases, 7 of 8 proved to be low-risk lesions; only 1 was high-risk. For the remaining 9 BD-IPMNs for which the guidelines suggested a non-operative approach, 2 high-risk lesions would have been missed. The sensitivity and specificity of the Sendai Consensus Guidelines are 33.3% and 36.4%. The PPV and NPV of the guidelines are 87.5% and 66.6%. The accuracy was 35.7%.

Conclusion: LIMITATIONS: Our study did not take into account symptoms or cytology results, and the design was retrospective. CONCLUSION: More precise risk ascertainment is needed in the management of BD-IPMNs. While our sample size is small, the Sendai Consensus Guidelines underestimated 2/3 high risk lesions and favored operative management in the majority of low-risk lesions. BD-IPMNs are rare in the United States and this was a multi-institutional study. Before a widespread guideline-based approach to pancreatic resection can be justified, further prospective evaluation of the current criteria in the United States is warranted.

181 Intraductal vs. Transpapillary FCSEMS Placement- Does It Make a Difference?

Alan Brijbassie, MD, M.B.B.S, Paul Yeaton, MD, FACG, Jennifer Maranki, MD. University of Virginia, Charlottesville, VA. Purpose: Fully covered self-expanding metal stents are used more frequently in benign and malignant biliary strictures. Stent patency is a determinant to

© 2011 by the American College of Gastroenterology

stent efficacy; we report upon whether patency is affected by trans-papillary (TP) vs. intra-ductal (ID) placement.

Methods: Two hundred and one patients with benign or malignant biliary strictures from a single university based medical center undergoing Fully Covered Self Expanding Metal Stent (FCSEMS) (Gore, Viabil) placement between November 2006-November 2009 were retrospectively analyzed to assess whether stent patency was affected by trans-papillary vs. intra-ductal placement. Patency was assessed by stent appearance at removal as well as the need for re-intervention due cholestasis or cholangitis.

Results: A total of 201 patients; 120 males (59.7%) (mean age 67.1 ± 12.2 yrs.) with benign as well as malignant strictures were retrospectively analyzed.

Benign etiologies (98) (48.8%) mainly consisted of choledocholithiasis (24) (24.5%), chronic pancreatitis (20) (20.4%), post-operative biliary leaks (16) (16.3%), post OLT anastomotic strictures (14) (14.3%) and post ampullary adenoma resection (11) (11.2%). Malignant etiologies (103) (51%) primarily consisted of strictures secondary to pancreatic cancer (68) (66.1%), cholangiocarcinoma (10) (9.7%), metastatic disease (7) (6.8%) and gallbladder cancer (2) (1.9%). A total of 121 (60.2%) stents were placed ID and 80 (39.8%) TP. Of the 121 placed ID, 50(41.3%) were used for benign indications and 71 (58.6%) for malignant. Of the 80 placed TP, 49 (61.3%) were for benign and 31 (38.8%) for malignant indications. Of the 80 TP stents, 35 (43.8%) were removed in an anticipated fashion. Of these, 10 (28.6%) (p = 0.002) were partially occluded with stent revision carried out in 5. Six patients (7.5%) presented with cholangitis (4 requiring stent revision) and 7 (8.8%) with cholestasis (6 requiring stent revision) (p = 0.028). Of the 121 ID stents, 42 (34.7%) were removed. Of these, 6 (14.3%) (p = 0.002) were occluded at removal. Seven patients (5.8%) presented with cholangitis (4 requiring stent revision) and 3 (2.5%) (p = 0.028) with worsening cholestasis. The biliary sphincterotomies that were carried out were partial and had no impact on the rate of stent occlusion in intraductal stents.

Conclusion: The role of duodeno-biliary reflux has been implicated in stent occlusion due to bacterial bio-film formation and de-conjugation of bile acids.

Intraductally placed stents may potentially negate or minimize this effect for both benign as well as malignant indications even in the presence of a partial sphincterotomy. Further study is warranted to assess long term efficacy in a prospective fashion.

182 The Association Between Aspirin/Nonsteroidal Anti-inflammatory Drugs and Pancreatic Cancer Revisited: An Updated Meta-analysis Augustine Salami, MD,1 Faris El-Khider, MD,2 Basile Njei, MD, MPH,4 Chobufo Ditah, MD,3 Ivo Ditah, MD, MPhil2. 1. Internal Medicine, Henry Ford Hospital, Detroit, MI; 2. Wayne State University, Detroit, MI; 3. University Of Yaounde, Yaounde, Cameroon; 4. University of Connecticut, Farmington, CT. Purpose: The association between aspirin (ASA)/ other nonsteroidal antiinflammatory drugs (NSAIDs) and pancreatic cancer remains controversial. A meta-analysis done in 2007 showed no association, but recent evidence continues to point to a possible protective effect of prolonged aspirin use on the risk of pancreatic cancer. The aim of this study was to incorporate recent evidence in an updated meta-analysis on the strength and direction of the association.

Methods: Two reviewers independently conducted a systematic search of the Cochrane Library, MEDLINE and PubMed database from 1960 to April 2011. Search terms included aspirin, NSAIDs, anti-inflammatory drugs combined with pancreatic and/or gastro-intestinal cancers. Identified articles were reviewed for additional references. Only studies reporting an effect measure for the association between ASA and/or other NSAIDs and pancreatic cancer were eligible for inclusion. In addition to overall effect of ASA/NSAIDs, subgroup analysis by study design(prospective vs retrospective), study setting(USA vs Other countries), duration of exposure (less than or greater than 5 years) and by exposure type ( ASA vs. other NSAIDs) were also performed. Analysis was done using the fixed effect model after a preliminary analysis showed no evidence of heterogeneity among all studies and subgroups. Publication bias was assessed using the Begg and Egger tests and visual inspection of funnel plot.

All analyses were done using STATA 11.

Results: Fourteen (nine prospective and five retrospective) studies were included in the analysis. The overall pooled effect estimate for both ASA and/or The American Journal of Gastroenterology

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NSAID use was 0.99 (95% CI 0.95-1.04). There was no significant association seen in the subgroup analysis by 1) study design: prospective (RR 0.99, 95% CI 0.94, 1.04), retrospective (RR 1.01, 95% CI 0.85, 1.20); 2) setting: USA(RR 0.98, 95% CI 0.92, 1.04), Other Countries (RR 1.01, 95% CI 0.93, 1.09); 3) duration of exposure: less than or 5 years (RR 0.97, 95% CI 0.87, 1.07), More than 5 years (RR 1.12, 95CI 0.91, 1.39); and 4) type of exposure: ASA (0.98, 95% CI 0.92, 1.03), NSAIDs (RR 1.03, 95% CI 0.94, 1.12). Table 1 summarizes the overall and subgroup analysis results.

Conclusion: Currently available evidence suggests that there is no association between ASA/other NSAIDs use and risk of pancreatic cancer. This result is not influenced by duration or type of exposure, and study design or country of study.

Absolute Number

Individual Complication Rate Percentage

Pancreatitis

96

2.42%

Infected Cysts

2

0.05%

Liver Abscess

1

0.025%

Cholangitis

7

0.18%

Hemobilia

1

0.025%

Stent Occlusion

81

2.0%

Stent Migration

55

1.4%

Pseudocyst

2

0.05%

Abscess

7

0.18%

Bleeding

15

0.38%

Publication bias

Guidewire Fracture

1

0.025%

Beggs

Exacerbation of Pain

8

0.2%

Fever

3

0.07% 0.05%

Table 1 Subgroups

Pooled effect(Effect estimate, 95% CI)

Heterogeneity I-squared

Overall exposure Exposure type

Study design

Study setting

Duration of study

0.99 (0.95,1.04)

P-value

[183] Summary of complications of endotherapy in treatment of chronic pancreatitis

Eggers

0.0

0.479

0.322

0.494

Complication

Duodenal Erosion

2

Aspirin

0.98 (0.92, 1.03)

0.0

0.520

0.243

0.322

Perforation

4

0.1%

NSAIDs

1.03 (0.94, 1.12)

10.9

0.344

1.000

0.956

Infection

8

0.20% 0.13%

Prospective

0.99 (0.94, 1.04)

9.0

0.357

0.493

0.586

De Novo Strictures

5

Retrospective

1.01 (0.85, 1.20)

0.0

0.475

0.308

0.253

Sepsis

11

0.28%

USA

0.98 (0.92,1.04)

18.5

0.273

0.180

0.550

Skin Wound from Lithotripsy

1

0.025%

Others

1.01 (0.93,1.09)

0.0

0.659

0.707

0.687

< 5 years > 5 years

0.97 (0.87, 1.07)

1.4

1.12 (0.91,1.39)

0.407

0.452

0.498

0.112

1.00

0.607

Cholecystitis Total ERCP Procedures: 3960

1

0.025%

Total Complications: 311

Total Complication Rate: 7.85%

Summary analysis of effects of various subgroups on the ASA/NSAIDs on the risk of Pancreatic Cancer.

183 Complications of Endotherapy in Chronic Pancreatitis Pain: A Systemic Review Javed Sadiq, MD, Mikram Jafri, MD, Frank Gress, MD, FACG. Internal Medicine, SUNY Downstate Medical Center, Brooklyn, NY. Purpose: Endotherapy is a beneficial therapy for chronic pancreatitis pain but there is limited available data on its complication rate. The aim of our study is to assess the complications of endotherapy through a systemic review.

Methods: A search of Medline, Embase and PubMed between 1989 to 2010 using search terms “Endotherapy,” “Chronic Pancreatitis” and “Stent placement in Chronic Pancreatitis.” We included Randomized Control trials, Observational studies and retrospective analysis. We excluded studies not in English, those with less than 10 patients, case series and studies which enrolled patients in alternate therapies, such as celiac plexus neurolysis. The data on complications was then extracted and analyzed.

Results: Our analysis included 16 studies totaling 1498 patients and 3960 ERCP procedures. Individual complications from each study were aggregated and compared against the total number of procedures. The compiled estimate of reported complications in endotherapy is 7.85%. The 3 most commonly reported complication included: acute pancreatitis in 2.4% of cases, stent occlusion in 2%, and stent migration in 1.4 %( Table 1).

Conclusion: Endotherapy has a lower complication rate (7.85%) in comparison with surgery, having major complications rate of 10.9% and minor complications rate of 28.3%*. Further, prospective multicenter trials comparing the duration of stent placement, optimal size (Fr), and composition/structure of stents need to be undertaken to obtain details on the complications of endotherapy and define its role as the first-line therapy in chronic pancreatitis pain.

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184 Is There a Role for Prophylactic Stenting to Prevent Pancreaticojejunostomy Anastomotic Strictures?

Samir Kapadia, MD,1 Brian Steiner, BS,2 Kamron Pourmand, BA,2 Philip Bao, MD,3 Juan Carlos Bucobo, MD,4 Jonathan Buscaglia, MD,4 Kevin Watkins, MD,3 Satish Nagula, MD4. 1. Stony Brook University Medical Center, Dept of Medicine, Stony Brook, NY; 2. SUNY at Stony Brook Medical School, Stony Brook, NY; 3. Stony Brook University Medical Center, Dept of Surgical Oncology, Stony Brook, NY; 4. Stony Brook University Medical Center, Dept of Gastroenterology and Hepatology, Stony Brook, NY. Purpose: Pancreaticojejunal anastomotic stricture (PJAS) is a complication following pancreaticoduodenectomy (PD). Stricture formation may lead to the development of exocrine pancreatic insufficiency, acute pancreatitis and diabetes mellitus (DM), leading to significant morbidity. The incidence of PJAS and their associated symptoms has not been well defined.

Methods: In this interim retrospective analysis, records from a random sample of 58 patients who have undergone PD at Stony Brook University Medical Center between 2006 and 2011 were reviewed. PJAS was defined by pancreatic ductal dilation seen on cross-sectional imaging. Rates of stricture formation, pancreatic insufficiency, pancreatitis, new-onset or worsening DM were assessed.

Results: Of the 58 patients included in this study (median age 66 years, range 33-91 years), 31 (53%) were female. Pathology revealed pancreatic adenocarcinoma (n=20, 34%), cholangiocarcinoma (n=7, 12%), intraductal papillary mucinous neoplasm (n=6, 10%), chronic pancreatitis (n=5, 9%), ampullary adenocarcinoma (n=5, 9%), other (n=15, 26%; duodenal adenocarcinoma, neuroendocrine tumor, benign pancreatic neoplasm). Radiographic evidence of PJAS was observed in 11 patients (19%), a median of 350 days after surgery (range 85 - 1824 days). Of these, 8/11 (73%) had exocrine pancreatic insufficiency despite oral enzyme supplementation, while the incidence was 32% (15/47) in those without PJAS (p = 0.012). Three patients (27%) with PJAS had multiple hospitalizations for acute pancreatitis compared to 0% in those without stricture (p=0.0002). Of the 11 patients with PJAS, 3 (27%) had new or worsening DM compared to 23% (11/47) in those without PJAS (p=0.90).

Conclusion: PJAS occur frequently after pancreaticoduodenectomy, identified in 19% of patients in this series. PJAS is associated with significant symptomatology, including pancreatic insufficiency and episodes of acute pancreatitis. Development of these symptoms warrants prompt radiographic evaluation for PJAS. Secretin stimulated MRCP may diagnose strictures prior to the development of ductal dilation, and thus may also help identify a relationship between PJAS and DM. Further studies regarding treatment of PJAS with ERCP and stent placement, as well as studies regarding prophylactic pancreaticojejunal stent placement for the prevention of PJAS, are needed.

185 Pancreatic and Duodenal Secretion Proteomic Profiling in Severe Acute Pancreatitis 2011 ACG Presidential Poster Junhai Ou, MD, MSc,1 Stephen O’Keefe, MD, MSc,1 Ru Chen, PhD2. 1. GI, University of Pittsburgh, Pittsburgh, PA; 2. University of Washington, seattle, WA. Purpose: Acute pancreatitis (AP) is an inflammatory disease of the pancreas, which evolves in approximately 20% of the patients to a severe illness associated with a high mortality rate. But so far, there is no good way to identify the severity and prognosis of AP. In this study, we performed a comparative proteomic analysis of pancreatic and duodenal secretion from human subjects with AP and healthy controls in order to identify changes in protein expression related to the pathobiological processes of this disease.

Methods: Pancreatic and duodenal secretion from 5 AP patients and 5 healthy volunteers matched with age, sex and BMI were stimulated by polymeric enteral feeding. 120 minutes after stimulation, the sample was collected through enteral feeding tube, and then analyzed by isotope-coded affinity © 2011 by the American College of Gastroenterology

tags (ICATs) and tandem mass spectrometry method. Briefly: Proteins from different samples were labeled with isotopically heavy (with 8 deuterium) and light (no deuterium) ICAT reagents, respectively, for quantitative analysis.

Two-dimensional LC separation, including SCX and RP-LC, was applied for fractionation of the samples before Mass spectrometry analysis.

Results: Total 241 proteins were identified, of which 96 proteins showed abundance increase and 15 proteins decrease at least two-fold in samples from AP compared to that from healthy volunteers, some of them being newly described in AP (Table). As anticipated, pancreatic enzymes were down-regulated. In addition, we observed increased expression of various inflammatory markers, including several members of the alpha-macro­ globulin family. We also detected changes related to oxidative and cell stress responses.

Conclusion: Proteomic analysis has the capacity to identify key regulators of the pathophysiologic mechanisms responsible for acute pancreatitis. Further functional studies are needed to determine the role these proteins play in injury and recovery.

Proteins up-regulated

Proteins down-regulated

REGENERATING ISLET-DERIVED PROTEIN 3 ALPHA.

PANCREATIC LIPASE-RELATED PROTEIN 2.

NEPRILYSIN.

ISOFORM A OF TRYPSIN-3.

DEFENSIN-6.

CHYMOTRYPSIN-LIKE ELASTASE FAMILY MEMBER 2A

ISOFORM 1 OF GLYCOSYLTRANSFERASELIKE PROTEIN LARGE2.

CARBOXYPEPTIDASE A1

ISOFORM 2 OF IG MU CHAIN C REGION.

PROTEOGLYCAN 3

186 Does Size Predict Malignancy in Mucinous Cystic Lesions of the Pancreas?

Chad Cornish, MD, Pari Shah, MD, Antonia Sepulveda, MD, PhD, Michael Kochman, MD, Colleen Brensinger, MS, Carlos Guarner-Argente, MD, Nuzhat Ahmad, MD. Hospital of the University of Pennsylvania, Philadelphia, PA. Purpose: To assess whether size greater than 3 cm is related to malignancy potential in mucinous cystic lesions of the pancreas, based on one institution’s experience.

Methods: All patients who underwent resection of a mucinous cystic lesion of the pancreas between January 1, 2000, and June 1, 2008, at the Hospital of the University of Pennsylvania, were identified by interrogation of the pathology database. Characteristics of the cystic lesions were reviewed. Measure of association was completed using the chi-squared test.

Results: A total of 123 patients were identified to undergo resection for mucinous cystic lesion of the pancreas within the time frame. Of these, 78 were diagnosed on pathology to be MCNs and 45 were diagnosed as IPMNs. Eight lesions did not have documented pathology size and were not included in the analysis. Table 1 includes a summary of characteristics. All lesions combined, 56 patients were found to have aggressive behavior on pathology, defined as moderate dysplasia, high-grade dysplasia or adenocarcinoma. A total of 67 patients were found to have non-aggressive features, defined as low-grade dysplasia or no dysplasia. Twenty-six (26) patients were found to have aggressive features and size less than 3 cm. Of these, 13 were MCN and 13 were IPMN. There was no statistically significant correlation between size greater than 3 cm and aggressive pathology (p=0.552).

Conclusion: Our results reveal no statistically significant association between size greater than 3 cm and malignancy potential. While this study has a relatively small number of patients and may be underpowered to detect a significant difference, 23% of all lesions had size less than 3 cm and aggressive pathology. Despite the Tanaka guidelines for management of branch IPMN, which uses size greater than 3 cm as a cut-off, all cystic lesions of the pancreas should be considered for resection.

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[186] Characteristics of mucinous cystic lesions > 3 cm (n=61)

< 3 cm (n=54)

MCN

43 (14 aggressive)

34 (13 aggressive)

IPMN

18 (12 aggressive)

20 (13 aggressive)

187 Increasing Incidence and Hospital Admissions for Cystic Neoplasm’s of the Pancreas: Change in Disease Biology or the Result of Increased Imaging Alphonso Brown, MD, MS Clin Epi. Beth Israel Deaconess Medical Center, Boston, MA. Purpose: The purpose of this study was to determine if the recent increase in hospital admissions for individuals with cystic neoplasm’s of the pancreas was due to a change in the biology of the tumor or was a result of finding more lesions due to increased investigative imaging of the pancreas.

Methods: Using data from the Nationwide Inpatient Sample (NIS) we analyzed the trends on all hospital admissions with a diagnosis of a cystic neoplasm of the pancreas (ICD9-211.6) from 1993-2009. The NIS is a national database which contains discharge data from 1,050 hospitals in 44 states in the U.S. The NIS sampling frame comprises approximately 95% of all hospitals in the U.S. We compared the trends to all hospital admissions with a primary diagnosis of pancreatic adenocarcinoma (PancCA) of the head (ICD9 157.0) and to PancCA of the body and tail (ICD9 157.1 and 157.2) for the period from 1993-2009. Since most PancCA of the head is symptomatic we hypothesized that if the incidence trends for PancCA of the head mirrored the trends of cystic neoplasm’s then this meant there was a true increased incidence of symptomatic cystic neoplasm’s of the pancreas. Since most body and tail lesions of the pancreas are incidentally found, we felt that if there incidence trends mirrored those of cystic neoplasm’s, then this would indicate the increase in cystic neoplasm’s were due to findings due to increased incidence at imaging.

Results: During the period from 1993-2009 there was an increase in hospital admissions for pancreatic cystic neoplasm’s of the pancreas from 617 in 1993 to a peak of 2,559 in 2008. During this same period admissions for PancCA of the body of the pancreas increased annually from 1,678 (1993) to a peak in 2008 of 2213. There was also a steady annual increase in admissions for PancCA of the tail of the pancreas from 1,454 (1993) to a peak of 2,941 in 2008. By contrast during the same period the admissions for PancCA of the head remained about the same: 15,018 (1993) - 15,346 in 2009.

Conclusion: These results indicate that during the period from 1993-2009 the incidence admissions for cystic neoplasm’s of the pancreas mirrored those for PancCA of the body and tail of the pancreas. The incidence of hospital admissions for PancCA of the head of the pancreas did not mirror that of these other lesions. Since most cystic neoplasms of the pancreas and lesions of the body and tail are found incidentally we hypothesize that the increase incidence and admissions during this period are the result of increased imaging and not a change in the biology of the disease. Further evaluation of outpatient incidence figures will be needed in order to further confirm these data.

188 Nasojejunal Feeding in Pancreatitis: A Single Center Experience Christopher Marshall, MD, Wahid Wassef, MD, Nicholas Smyrnios, MD, Gisele Leblanc, MS, RD, LDN, CNSD. Gastroenterology, University of Massachusetts Medical School, Worcester, MA. Purpose: The traditional standard practice for the management of acute pancreatitis has been bowel rest and pain control. With recent data, though, this paradigm is shifting toward early enteral feeding as way of providing nutrition and possibly decreasing complication and cost of parenteral nutrition. We have retrospectively reviewed 10 patients where a nasojejunal tube was placed for feeding in acute pancreatitis.

The American Journal of Gastroenterology

Methods: Inpatient records reviewed for patients admitted for acute pancreatitis at our institution who underwent endoscopic nasojejunal placement. We examined demographic data, ICU length of stay, hospital length of stay and clinical outcomes. In all cases either a pediatric upper endoscope or the Olympus XP 180N ultraslim gastroscope was inserted into the nares. A guidewire (0.035 mm hydrophilic wire) was placed under direct vision and fluoroscopy (when available). The endoscope was subsequently removed and either a 10fr or 16fr nasojejunal tube was advanced over the wire into the small intestine and confirmed under fluoroscopy or subsequent xray.

Results: From February 2010 through October 2010 a total of 17 endoscopies for the purpose of Nasojejunal feeding were performed in 10 patients. The average Ranson score was 4.75 (range1-8). Most patients were managed in the ICU as part of their admission with an average stay of 31 days. Immediate success was achieved in 82.4% (14 of 17 cases). A total of 5 patients needed to undergo repeat procedures (dislodgement: 3; malfunction: 2). The average duration of nasojejunal feeding was 14.3 days for each procedure and 22.9 days for each patient when one includes replacement. Two patients were able to be discharged home with their tubes in place while receiving enteral feeds. The reason for discontinuation varied, but included dislodgement (intentional or unintentional) in four patients, malfunction (either blocked or kinked) in two patients, tolerating diet in two patients, or surgical placement of a jejunal tube in two patients.

Conclusion: Nasojejunal feeding is an acceptable alternative to parenteral nutrition in patients with acute pancreatitis. Endoscopic placement is achievable in greater than 80% of cases with 50% of patients needing repeat endoscopic placement. It is also possible to manage some patients on an outpatient basis with nasojejunal feeding.

189 Correlation Between EUS and Histopathology in 50 Patients Undergoing Total Pancreatectomy (TP) with Islet Autotransplantion (IAT) for Minimal Change Chronic Pancreatitis (MCCP) ACG Auxiliary Award Jose Vega-Peralta, MD, Carlos Manivel, MD, Rajeev Attam, MD, Mustafa Arain, MD, James Mallery, MD, David Radosevich, R.N., PhD, Firas Khamis, MD, Melena Bellin, MD, Srinath Chinnakotla, MD, Ty Dunn, MD, Aasma Shaukat, MD, Gregory Beilman, MD, David Sutherland, MD, Martin Freeman, MD. University of Minnesota, Minneapolis, MN. Purpose: Diagnosis of minimal change (non-calcific) chronic pancreatitis (MCCP) is challenging and controversial. Endoscopic ultrasound (EUS) has been widely used for diagnosing MCCP using 9 standard criteria, however, these criteria are derived from correlation between EUS and histology from patients (pts) undergoing resection for conditions other than MCCP. The aim of our study was to investigate the correlation between EUS findings and histo­ pathology in pts undergoing total pancreatectomy with islet autotransplantation (TP-IAT) for painful MCCP. Methods: We retrospectively compared EUS findings (obtained <1 year prior to surgery) with histopathology of the pancreas in 50 adults and children with MCCP (no calcifications on abdominal CT) from a total of 141 pts undergoing TP-IAT at a single center from 1/2008 through 7/2010. EUS abnormalities were classified using 9 standard criteria. Pts were selected for TP-IAT by a multidisciplinary committee based on intractable disabling pancreatic pain, absence of correctable etiology, refractory to maximal endoscopic therapy, plus MCCP based on the following criteria: documented history of acute recurrent pancreatitis, or abnormality in at least 2 of the following 3 tests: 1) EUS (≥4/9 criteria), 2) secretin stimulated MRCP with ductographic abnormalities or decreased T1 parenchymal signal, 3) abnormal endoscopic pancreatic function test (peak bicarbonate concentration <80 mM/L). Histology was obtained from resected pancreas by wedge biopsy of head, body and tail when possible (mean # of biopsies 2.6). Histopathology was evaluated by a blinded pancreas pathologist. MCCP was determined as present histologically when fibrosis, atrophy or inflammation was found in at least one post resection biopsy.

Results: MCCP using composite of any of 3 abnormalities was found at histopathology in 45/50 (90%) pts. All 45 (100%) pts had fibrosis. The 5 pts (10%) with normal histology all had a documented history of acute recurrent pancreatitis in addition to disabling pain. Of pts with histologically confirmed MCCP, Volume 106 | supplement 2

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27/45 (60%) had ≥4/9 criteria on EUS. 18/21 (85%) pts with ≤3 EUS criteria and 4/5 (80%) pts with 0/9 EUS criteria had both fibrosis and MCCP by histopathology. 2/29 (7%) pts with ≥4/9 EUS criteria had normal histology. AUC was 0.593, Kappa Coefficients <0.11 for all cutoff points. Negative predictive value of a normal EUS was only 38%, and positive predictive value of abnormal EUS only exceeded 72% at ≥6 criteria.

Conclusion: Correlation between EUS and histopathology of minimal change chronic pancreatitis is poor in pts undergoing TP-IAT. Normal or nearly normal EUS cannot be used to exclude MCCP, and abnormal EUS alone is probably not sufficient for the diagnosis unless ≥6 criteria are present.

190 Allopurinol for Prophylaxis Against Post ERCP Pancreatitis: A Metaanalysis of Randomized Controlled Trials Jonathan Nass, MD, Praveen Roy, MD, Mainor Antillon, MD, Ramon Rivera, MD. Gastroenterology, Ochsner Clinic, New Orleans, LA. Purpose: Post-ERCP pancreatitis is a common complication after ERCP and contributes significantly to the morbidity and mortality of the procedure. A number of pharmacologic agents have been evaluated in an attempt to identify a strategy to reduce post ERCP pancreatitis with only mixed success. Based upon data from animal studies, allopurinol, a free radical scavenger, may prevent the cascade of inflammation in post ERCP pancreatitis. Since 1991, a number of large randomized controlled trials have been conducted to evaluate this effect with mixed results. We conducted a meta-analysis of the randomized controlled trials (RCTs) to evaluate the efficacy of prophylactic allopurinol in the prevention of post-ERCP pancreatitis.

Methods: Medline, Cochrane Central Register of Controlled Trials & Database of Systemic Reviews, PubMed, and recent abstracts from major conference proceedings were searched through 11/10. RCTs comparing prophylactic allopurinol to placebo in patients undergoing ERCP were included. Standard forms were used to extract the data by two independent reviewers. The effects of prophylactic allopurinol were analyzed by calculating pooled estimates of post ERCP pancreatitis. Summary odds ratio was calculated using Comprehensive Meta-Analysis software. Publication bias was assessed by funnel plot. (Figure 1) Heterogeneity among studies was assessed by calculating 12 measures of inconsistency.

Results: Seven RCT (N=2305) met the inclusion criteria. The studies were reported from the U.S., Canada, Mexico, Greece and Poland. Heterogenity was present and thus a random effect model was used for the analysis. Overall prophylactic allopurinol did not decrease the odds of developing post ERCP pancreatitis OR 0.70(95% CI: 0.36-1.36 p=0.29). (Figure 2) In subgroup analysis no differences were noted in the incidence of post ERCP pancreatitis with respect to the dosing of allopurinol. High dose allopurinol (1.2 g administered within 24hrs of the procedure) did not reduce the incidence of post ERCP pancreatitis OR 0.87 CI 0.61-1.24 p= 0.431), nor did low dose allopurinol (400 mg or less administered within 24hr of the procedure (OR 1.41, 95%CI 0.812.46 )). The time of administration of allopurinol also did not have an effect on the rate of post ERCP pancreatitis. Loading the patient > 5 hrs prior to the procedure did not affect the rate of post-ERCP pancreatitis (OR 0.44, 95% CI :0.14-1.39 p=0.16). Similarly drug dosing <5hrs prior to the procedure had no effect on the rate of pancreatitis. Publication bias was not present. Pooling of data from high quality studies (Jadad score >3) also did not reveal a reduction in the odds of pancreatitis.

Conclusion: Prophylactic allopurinol does not prevent post ERCP pancreatitis.

191 Combining Fine-Needle Aspiration (FNA) and Fine-Needle Core Biopsy (FNCB) Using a Standard 22 Gauge EUS Needle Increases Diagnostic Yield 2011 ACG Presidential Poster Charles Chaya, MD, Brian Lim, MD, MCR. Kaiser Permanente Riverside Medical Center, Riverside, CA. Purpose: EUS guided needle aspiration for cytology has limitations in diag­ nosis of diseases such as lymphoma and stromal tumors. Core biopsies for © 2011 by the American College of Gastroenterology

histologic information have been traditionally performed using 19 gauge trucut needles but usage of these devices in certain anatomic locations can be challenging. There is paucity in data examining the utility of standard 22 gauge needles in obtaining core biopsies and such method as a supplement to the traditional FNA. Current study explores combining EUS FNA with FNCB to increase the diagnostic yield.

Methods: EUS performed between December 2009 and November 2010 in a single community hospital setting were retrospectively reviewed, and cases which used both FNA and FNCB (with standard FNA needles rather than 19 gauge trucut needles) were selected. Cases were reviewed for procedural details, FNA cytology results, FNCB histopathology results, and confirmation of final diagnoses. FNAs were performed with 25 gauge and/or 22 gauge needles. FNCB were performed with 22 gauge needles.

Results: Total of 21 cases meeting the criteria were identified. Diagnoses of the lesions sampled were as follows: lymphoma (4), pancreatic carcinoma (5), GIST (5), undifferentiated carcinoma of pancreas with giant cells (1), splenule (1), schwannoma (1), autoimmune pancreatitis (1), benign mass with mixed lymphocytes (1), gastric adenocarcinoma (1), and carcinoid tumor (1). 18/21 (85.7%) cases were accurately diagnosed with the combined method. Sensitivities of FNA, FNCB, and the combined method were 47.4%, 52.6% and 84.2%, respectively. Specificities were 100% for all methods.11 cases revealed nondiagnostic FNA cytology, of which FNCB was able to yield accurate diagnoses in 7 cases (63.6%).

Conclusion: FNCB with 22 gauge EUS needles can be employed as a supplement to FNA in diagnosis with high accuracy, especially in cases where usage of traditional 19 gauge trucut needles can be technically difficult. This would be particularly useful when immediate cytological feedback is not available.

More studies are needed to prospectively compare the different EUS tissue sampling methods available.

192 Fully Covered Self- Expandable Metal Stents (FCSEMS) in the Management of Benign Biliary Strictures Sheila Bharmal, BS, Jamie Sodikoff, BA, Sagar Garud, MD, Nilofer Kulam, BS, MPH, Field Willingham, MD, Qiang Cai, MD, FACG, Steven Keilin, MD. Gastroenterology, Emory University Hospital, Atlanta, GA. Purpose: Plastic biliary stents have been the mainstay of endoscopic management of benign biliary strictures. However, plastic stents are small in diameter and may fail to resolve a significant subset of benign strictures. Fully covered self-expandable metal stents (FCSEMS) may be used successfully for management in strictures refractory to conventional plastic stenting.

Methods: A retrospective chart review of 1015 ERCP procedures performed within an 18-month period at a tertiary academic medical center. In those cases included, stricture resolution by cholangiography, improvement in hepatic enzymes, stent removability, and peri-procedural complications were assessed.

Results: Of the 1015 cases in the study period, 27 FCSEMS were placed in 24 patients for benign biliary strictures. Indications for management of benign biliary strictures were anastamotic stricture after orthotopic liver transplant (n=12), stricture secondary to choledocholithiasis (n=4), chronic pancreatitis (n=3), primary sclerosing cholangitis (n=2), IPMN (n=2) and periampullary diverticulum (n=1). All patients had previously failed management with plastic stents. To date, stent removal was attempted in 21/27 cases. In those cases in which stent removal was successful, stricture resolution was achieved in 15 (71%) cases and 14 (74%) patients, while 5 (26%) patients had a persistent stricture despite FCSEMS. A trend towards a decrease in liver enzymes was observed after FCSEMS placement, although it was not statistically significant. Successful stent removal occurred in 18 of 21 (86%) patients attempted after a median of 119 days. Failure of stent removal occurred in 3 (14%) cases, two secondary to stent migration and one secondary to inability to remove from bile duct. Complications were noted in 7 (29%) patients undergoing stent placement and 1 (5%) patient undergoing stent removal, including pancreatitis (n=4), cholangitis (n=2), bacteremia (n=1), and nausea/vomiting (n=1).

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Conclusion: In our review, FCSEMS were successful in stricture resolution in 71% of plastic stent failures. There were no deaths, however about one third of patients had a complication, which were managed conservatively. Given the potential morbidity associated with surgical management of benign biliary strictures, use of FCSEMS may prove to be a feasible option. A prospective randomized controlled trial could allow for better comparison of plastic stents and FCSEMS.

193 Does Cyst Fluid CEA Level Correlate with Malignancy Potential in Mucinous Cystic Lesions of the Pancreas?

Chad Cornish, MD, Pari Shah, MD, Antonia Sepulveda, MD, PhD, Gregory Ginsberg, MD, Michael Kochman, MD, Colleen Brensinger, MS, Carlos Guarner-Argente, MD, Nuzhat Ahmad, MD. Hospital of the University of Pennsylvania, Philadelphia, PA. Purpose: To determine if cyst fluid CEA can be used to differentiate between benign and malignant cystic neoplasms of the pancreas.

Methods: A retrospective case control study was conducted; all mucinous pancreatic cystic lesions that have been surgically resected at one institution from January 1, 2000, to June 1, 2008, were identified and reviewed. Information on cyst fluid CEA level was retrospectively gathered.

Results: A total of 123 mucinous cystic lesions of the pancreas were resected at the Hospital of the University of Pennsylvania within this time frame. Of these, 91 patients underwent endoscopic ultrasound (EUS) evaluation prior to surgical resection. Of these, 30 patients had cyst fluid CEA evaluated. Table 1 describes cyst fluid CEA level by lesion type. There was no significant association identified between CEA level (per 1000 unit increase) and aggressive behavior of the lesion, defined as moderate dysplasia or higher (OR 1.004, 95% CI 0.974-1.035).

Conclusion: While cyst CEA level can be used to differentiate between mucinous and non-mucinous cystic lesions of the pancreas, it does not allow the clinician to determine malignancy potential of mucinous cystic lesions of the pancreas.

Results Non-aggressive Total

Aggressive Total

Mean CEA

MCN

51

27

IPMN

16

29

Lesion

Mean CEA Nonaggressive (#)

Mean CEA aggressive (#)

7223

362 (12)

23688 (5)

8767

22629 (5)

104 (8)

194 Pregnancy Associated Pancreatitis - Revisited Osamuyimen Igbinosa, MD, Capecomorini Pitchumoni, MD, FACG, Sameer Poddar, MD. St. Peter’s University Hospital, New Brunswick, NJ. Purpose: Acute pancreatitis in pregnancy or postpartum (PAP) was once considered life threatening to the mother or fetus. Generalization from previous studies in current age has become obsolete. AIM: To study the demographics, incidence, etiology and complications of PAP. Methods: Using the diagnostic code of acute pancreatitis (577.0) we reviewed charts of women of ages 18 to 45 from Saint Peter’s University Hospital database between 2005 and 2009. Serum amylase and lipase levels above 3 times normal were the diagnostic indicators, in addition to history of abdominal pain. Acute pancreatitis within 6 months of childbirth was considered postpartum and included in the study.

Results: During the 4 years of the study, 29 cases of PAP occurred among 25,600 deliveries, yielding an incidence of 0.1 per year. Ethnicity of women with PAP was: Hispanic (Mexican/Central American) 48%, Caucasian 24%, African American 17.2%, and Asian/Pacific Islander 10.3%, as compared to that of controls of 31%, 41%, 15%, and 12% respectively. Majority of the PAP The American Journal of Gastroenterology

cases were associated with gallstones (72.4%), with only 3.4% related to alcohol. PAP occurs more frequently in later trimester (65%), with 33% in second and 2% in first trimester. The occurrence of PAP was distributed across a range of gestational ages, with more cases presenting later in gestation: 2%, 33% and 65% in 1st, 2nd and 3rd trimesters, respectively. Pre-pregnancy BMI of >30 was present in 65% of PAP cases as compared to 24% that of controls. There were no maternal or fetal deaths in the perinatal period.

Conclusion: 1. Gallstone disease is the most frequent etiology for PAP. 2. PAP tends to occur more often in Hispanics in New Jersey perhaps a reflection of high prevalence of gallstone disease. 3. Obesity is a frequent co-morbid factor in PAP. Obesity itself is a predictor of severe pancreatitis. 4. In this pilot study, there was no significant fetal or maternal mortality but there was a trend towards prematurity. It is appropriate to screen Hispanic women for gallstones by extending the sonogram regularly performed to evaluate the uterus and fetal growth to include the gallbladder. The benefit is the awareness of the risk for PAP. Reference Pitchumoni CS and Yegneswaran B. Acute pancreatitis in pregnancy. World J Gastroenterol 2009; 15(45): 5641-5646.

SMALL INTESTINE/UNCLASSIFIED 195 Giardia Infection: A Demographic, Geographic and Seasonal Review of 138 Consecutive Cases Over a Three Year Period Jeremy Ditelberg, MD, Caris Life Sciences, Newton, MA. Purpose: Giardia infection is the most common parasitic infection affecting the small intestine in the United States. This study was undertaken to describe the demographic, seasonal and geographic characteristics of Giardia infection in the United States.

Methods: Patients with a diagnosis of Giardia infection were selected from the database of Caris Life Sciences, a specialized gastrointestinal pathology group receiving specimens from community-based gastroenterologists in 42 states, Washington, D.C. and Puerto Rico. The database includes demographic and clinical information, summary of the endoscopic report, biopsy location, and the histopathologic report for each biopsy. Cases of Giardia with a report date from 11/01/07 to 10/31/10 were extracted from the database.

Results: A total of 138 patients with Giardia infection from 24 different states were recovered. There were 74 males (53.6%) and 64 females (46.4%). The mean age at diagnosis was 46.9 years (median was 48.5 years, range 1 to 84 years).

The overall percentage of Giardia infection in those states with at least one case of Giardia was 0.13% of all duodenum and small intestine biopsies with a range of 0.05% to 0.31% (see table). The top five states were CT, AK, SC, DE and OK. The percentage of all duodenal and small intestinal biopsies with Giardia infection by month was: January (0.10%), February (0.09%), March (0.19%), April (0.16%), May (0.08%), June (0.10%), July (0.15%), August (0.08%), September (0.10%), October (0.13%), November (0.13%) and December (0.11%).

Conclusion: In this population, the age distribution of Giardia infection follows a bell-shaped curve with a plateau from age 30-69. Although geographic distribution by state showed a six-fold difference between the lowest and the Number/percentage of patients diagnosed with giardia infection by age Age range

Number of patients

Percentage of 138 patients

0–9

8

5.8

10–19

5

3.6

20–29

12

8.7

30–39

26

18.8

40–49

21

15.2

50–59

22

15.9

60–69

27

19.6

70–79

14

10.1

80–89

3

2.2

Volume 106 | supplement 2

| October 2011

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