Gastroenterology Today - Spring 2015 by Media Publishing Company

Volume 25 No. 1

Spring 2015

Gastroenterology Today For the precise and fast in vivo detection of Helicobacter pylori

…breathtakingly precise Torbet Laboratories Ltd., Unit 1 Chestnut Drive, Wymondham, Norfolk, NR18 9SB. Tel: 01953 607856 Fax. 01953 713649 E-mail: customerservices@torbetlaboratories.co.uk

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12/02/2015 12:09

Contents

Contents 5

Editors Comment

NEWS

FEATURE N o Correlation between the Month of Birth and the Likelihood of Developing Inflammatory Bowel Disease Later in Life

BSG POSTERS

COMPANY NEWS

Gastroenterology Today This issue edited by: Dr M Goldman BSc, MBBS, MRCP, FFPM c/o Media Publishing Company Media House 48 High Street SWANLEY, Kent BR8 8BQ ADVERTISING & CIRCULATION: Media Publishing Company Media House, 48 High Street SWANLEY, Kent, BR8 8BQ Tel: 01322 660434 Fax: 01322 666539 E: MPCJournalss@aol.com www.MediaPublishingCompany.com PUBLISHING DATES: February, June and October.

Cover Story Pylobactell is a 13C-urea breath test kit for the in vivo detection of gastroduodenal Helicobacter pylori (H. pylori) infection. It has been in use since the 1980s around Europe before being granted a European medicinal licence in 1998. Torbet Laboratories Limited is the Marketing Authorisation Holder for Pylobactell and also runs an ISO 17025 accredited testing laboratory for the analysis of the resultant breath samples. The aim of the laboratory is to return results within two working days of receipt. Used extensively in primary and secondary care, Pylobactell is also licensed for use at home, further minimising service provision costs and circumventing cultural and personal issues associated with other diagnostic testing. The test is non-invasive, easy to perform, highly specific and sensitive to H. pylori. Pylobactell can be used in pregnant women but should be avoided in patients with partial gastrectomy.

More information is available from: Torbet Laboratories Ltd, Unit 1 Chestnut Drive, Wymondham, Norfolk, NR18 9SB Tel: +44(0)1953 607856 Email: customerservices@torbetlaboratories.co.uk

PUBLISHERS STATEMENT: The views and opinions expressed in this issue are not necessarily those of the Publisher, the Editors or Media Publishing Company. Next Issue Summer 2015 Subscription Information – Spring 2015 Gastroenterology Today is a tri-annual publication currently sent free of charge to all senior qualified Gastroenterologists in the United Kingdom. It is also available by subscription to other interested individuals and institutions. UK: Other medical staff - £18.00 inc. postage Non-medical Individuals - £24.00 inc. postage Institutions Libraries Commercial Organisations - £48.00 inc. postage Rest of the World: Individuals - £48.00 inc. postage Institutions Libraries Commercial Organisations - £72.00 inc. postage We are also able to process your subscriptions via most major credit cards. Please ask for details. Cheques should be made payable to MEDIA PUBLISHING. Designed in the UK by Hansell Design

Gastroenterology Today - SPRING 2015

H. pylori is the most widespread infection in the world with high infection rates in developing countries and with population movement, within migrant populations from affected countries. Infection with H pylori commonly causes dyspepsia and peptic ulcer disease and the Maastricht consensus report recommends ‘test and treat’ for this patient population thus avoiding the cost, discomfort and inconvenience of endoscopy. This strategy is suitable in situations where the risk of gastric cancer is low and no ‘alarm’ symptoms are present.

12:09

How to stop patients saying this ... I will not have another colonoscopy as it causes too much pain!*

It was absolute agony. I don’t think I will ever go back for another one!*

On a scale of 1-10 I would say the pain was 15 ...NEVER AGAIN!*

Both colonoscopies were terminated part way through because she was crying out in pain. My wife has since declined the invitation for a third!*

The Solution...

The World’s First Painless Colonoscope Interested? Visit: www.painlesscolonoscopy.co.uk or email: sales@pfemedical.co.uk Partners for Endoscopy Ltd, Hartley House, Galveston Grove, Fenton, Stoke-on-Trent ST4 3PE

Editors comment

Editors Comment A shift in the way we look for evidence. It cannot have escaped your attention that there are going to be new regulations in Europe covering the way that clinical trials are organised, conducted and reported. The old clinical trial directive has been superseded and in 2016 the new regulations should come into force. This will, in particular, make it easier and quicker for clinical studies to start and will clarify how cooperative groups will run studies. What is spectacularly interesting will be the new rules on transparency, and the bottom line is that all approved studies will be put into the public domain once completed unless there is information that is truly commercial in-confidence. This will potentially bring benefit to many parties, and studies that are negative will now come to the attention of those that want to know. Given the comments that were made by Ben Goldacre in his book ‘Bad Pharma’ about big pharma seeking to misrepresent clinical studies in their promotion, there will be no hiding place for data. Full clinical study reports will be available when a particular clinical study has been used for the application for a marketing license. In parallel with these developments, an increasing interest in studies that generate ‘Real World Evidence’ has become apparent, and these studies are becoming more widely accepted for all sorts of purposes. What makes them very different from clinical trials is the methodology, which derives the data retrospectively, and typically these are labeled as noninterventional studies. These retrospective non-interventional studies lay outside the clinical trial regulations, and may therefore not come to the attention of researchers. Nevertheless, they are particularly important as they often relate what happens in the real world when a particularly treatment is used by prescribers. The information is therefore more likely to reflect the real world and therefore must not be ignored. Between the two are studies based on disease registries. These are definitely fashionable as they offer a way for all practitioners to pool data about particular diseases and treatment pathways. The output from registries, which gives a contemporary snapshot of how patients are managed, and permit goals to be more clearly set. The registries may be used for retrospective surveillance, or prospectively to answer specific questions that need big numbers of patients and long observation periods. I spoke to Richard Driscoll, who is now deeply involved in the inflammatory bowel disease registry in the UK. He told me that at the moment, only about 2% of UK IBD patients are currently entered into this national registry and it is planned that 20% will be in the registry by the end of 2016 which means there may be a way to go before the big picture is known. The registry offers an opportunity to collect and analyse the treatment pathways for patients and benchmark the way patients with IBD are managed. I would commend this work to you and encourage all involved with IBD to enter patient data into the registry in order to maximise its usefulness.

Gastroenterology Today - SPRING 2015

“What is spectacularly interesting will be the new rules on transparency, and the bottom line is that all approved studies will be put into the public domain once completed unless there is information that is truly commercial in-confidence”

NEWS Barrett’s oesophagus patients preferred endoscopic intervention for oesophageal adenocarcinoma

BE (65% men; 96% white; mean age, 60.2

E. DeBakey VA Medical Center and Baylor

years) enrolled at Vanderbilt University Medical

College of Medicine, Houston, Texas.

Center, University of Colorado Hospital and the Veterans Administration Eastern Colorado

The study’s strength is that its participants

Health Care System between May 2011 and

share similarities with patients at risk for BE, and

October 2013.

among these typical patients, 16% endorsed neither method and 47% were willing to try

Researchers described the risks and benefits

both methods, according to Naik and El-Serag.

of the two treatments anonymously to patients.

However, the study’s limitations included

Patients with Barrett’s esophagus preferred

They explained treatment A (ablation) as an

inferences about the efficacy of ablation that

endoscopic ablation over chemoprevention for

upper endoscopic treatment to remove BE

are not well-supported, a potential framing bias

prevention of oesophageal adenocarcinoma,

tissue and reduce lifetime EAC risk by 50%

resulting from endoscopy being consistently

according to study data.

(from 10% to 5%). They told patients treatment

presented before oral chemoprevention,

B (aspirin) was a once daily over-the-counter

and a lack of a sensitivity analysis that varied

“In a hypothetical scenario, assuming

pill to reduce lifetime EAC risk by 50% (from

estimates of benefit from ablation.

comparable efficacy and known risks, more

10% to 5%). Participants were asked if they

patients with Barrett’s esophagus [BE] would

would be willing to undergo each treatment if

“These limitations may result in an artificially

choose an endoscopic intervention than

surveillance endoscopy was required every 3-5

higher preference for surveillance endoscopy

chemoprevention for oesophageal cancer

years, every 10 years or never.

on the questionnaire compared with its actual

prevention,” Patrick S. Yachimski, MD, from

selection in routine clinical practice,” they wrote.

the division of gastroenterology, hepatology

When surveillance endoscopy was required

and nutrition at Vanderbilt University

every 3-5 years, 78% of patients chose

Medical Center in Nashville, told Healio

ablation compared with 53% who chose

Gastroenterology. “Understanding such patient

aspirin (P<.01). The researchers found no

preferences and the motivations behind these

differences in age, sex, education level or

preferences may have implications for design

history of cancer, heart disease or ulcer

of future oesophageal cancer prevention

in patients who chose ablation vs. those

strategies.”

who chose aspirin. Altering frequency of surveillance endoscopy had no significant

Researchers aimed to learn whether

influence on patients’ willingness to undergo

patients with nondysplastic BE in a

either treatment.

Complex genome-microbiome link may influence risk for IBD “The intestinal bacteria, or ‘gut microbiome,’ you develop at a very young age can have a big impact on your health for the rest of your life,” Dan Knights, PhD, assistant professor in the department of computer science and engineering and the Biotechnology Institute

surveillance program preferred endoscopic intervention or chemoprevention to protect

This study “is an important contribution to

against the development of oesophageal

the growing literature on shared decision-

adenocarcinoma(EAC) and to learn if altering

making in gastroenterology and hepatology,”

endoscopic surveillance frequency affects

according to an accompanying editorial written

patient selection of either option. Researchers

by Aanand D. Naik, MD, and Hashem

surveyed 81 participants with nondysplastic

B. El-Serag, MD, MPH, from the Michael

at the University of Minnesota, said in a press release. “We have found groups of genes that may play a role in shaping the development of imbalanced gut microbes.” Knight and colleagues tested known IBDassociated genetic loci for links to taxonomic composition of gut microbiota in three independent cohorts that included 474 adults

Faecal Calprotectin Sample Collection and Extraction Now Made Quick and Easy

with IBD (aged 18-75 years) from the United States, Canada and the Netherlands. They

Gastroenterology Today - SPRING 2015

collected 16S ribosomal RNA gene sequences

Users of the BÜHLMANN range of calprotectin assays can now benefit from improved efficiency and laboratory workflow with the unique, new, CALEX® Cap sample collection and extraction device.

from intestinal biopsies and host genotype using the Immunochip platform. They then tested for correlations between relative abundance of bacterial taxa and the number

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of minor alleles at 163 genetic loci known to be associated with IBD risk, specifically targeting the nucleotide-binding oligomerization domaincontaining protein 2 (NOD2) gene exon.

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Across two cohorts, they found that there was a significant association between NOD2 risk allele count and increased relative abundance Alpha Laboratories Ltd 40 Parham Drive Hampshire SO50 4NU UK

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of Enterobacteriaceae, with a similar trend observed in the third cohort. Microbiota associations with significance validated by a

Gastro-Today_Calex-Cap_FINAL_Jan15.indd 1

22/01/2015 11:33:20

NEWS false discovery rate of less than 0.25 also were

she has experienced a rise in the number of

of moderate depression and suicidality, and

detected for 48 other host genes. They also

patients seeking treatment for liver-related

also identify the characteristics of patients

found that antibiotics are an additional risk

illnesses. Data from the National Office of

most at risk for depression and suicidality to

factor for IBD-related microbial dysbiosis.

Statistics reveals liver disease is now the third

help prevent them earlier. During routine GI

biggest cause of premature death with 62,000

visits, they screened patients for depression

years of working life lost every year in the UK.*

and suicidality using the patient health

“Although our data are cross-sectional and therefore cannot define causality, our

questionnaire (PHQ9), assessed disease

analyses demonstrate complex host genetic

Liver disease can be caused by a wide variety

activity using the Harvey-Bradshaw CD Index

associations with taxonomic and metabolic

of conditions affecting people off all ages and

or the UC Activity Index, evaluated QOL

dysbiosis in humans,” the researchers wrote.

from all walks of life. The British Liver Trust (a

“These include implications of microbiome-

non-profit organisation, offers people with liver

using the Short IBD Questionnaire (SIBDQ)

wide associations with TNFSF15, IL12B, and

disease valuable support ensuring they don’t

with innate immune response, inflammatory

face the disease alone.

response, and the JAK-STAT pathway, as well as NOD2-related increases in

Dr Anne McCune will be flying out to the

Enterobacteriaceae relative abundance.”

Sahara desert on the 6th March and will return on the 15th March. To sponsor her, please visit

“In many cases, we’re still learning how these

her Justgiving page www.justgiving.com/Anne-

bacteria influence our risk of disease, but

McCune

understanding the human genetics component is a necessary step in unravelling the mystery,”

Read more: http://www.bristolpost.co.uk/

Knights said.

STEPPING-CHALLENGE-BRISTOLCONSULTANT-S-CAMPAIGN/story-25888096-

Stepping up to the challenge Bristol consultant’s campaign to fight deadly liver disease

detail/story.html#ixzz3PNLsfLsV

Pushing herself to her limits, Spire The Glen

Severity of depression associated with disease activity, QOL in IBD patients

Hospital Bristol’s expert gastroenterology and hepatology consultant, Dr Anne McCune, has vowed to complete a 100k trek across the

Sahara Desert to raise much-needed funds for the British Liver Trust.

ORLANDO, Fla. — The severity of depressive symptoms among patients with inflammatory

Setting off in March, the 48-year-old consultant,

bowel disease was associated with disease

will endure extreme temperatures, struggle

activity and related quality of life, while

through knee-deep sand and tackle 1,000ft

suicidality was more associated with severity

dunes to raise money in memory of her father,

of depression rather than disease activity,

David McCune, who sadly passed away after

according to a presenter here.

losing his fight with liver cancer in April 2014. “Depressive symptoms are common among patients with IBD, but clinical correlates of

McCune commented: “When I tell people what

more severe depression and suicidality

I’m doing, many ask whether I’m having a mid-

have not been systematically examined in

life crisis as I am not fantastically fit, I despise

IBD patients,” Victor Chedid, MD, from the

creepycrawlies and I like my home comforts.

University of Pittsburgh, said in a presentation.

However, I will continue to train hard until

“The most disturbing behavior linked to

March and am determined to complete the

depression is suicidality, and it has been

challenge and raise money for such a worthy

understudied in IBD.”

narcotic use, pain and prior surgery from electronic medical records. Overall, mean SIBDQ score was 51, pooled mean IBD activity was 4.25, 27% had acute pain, 23% were on narcotics, 51% had IBDrelated surgery, 23% had at least moderate depression and 7% reported suicidality. Among patients with moderate depression, mean PHQ9 score was 14.5, mean SIBDQ score was 35, pooled mean IBD activity score was 7.3, 25% were suicidal, 55% reported acute pain, 41% were on narcotics and 58% had IBD-related surgery. SIBDQ, IBD activity, narcotic use, pain and surgery correlated with severity of depression (P<.05), and regression modeling including these variables explained 61% of variance in depressive severity and disease activity. SIBDQ, depressive severity, IBD activity pain and surgery were predictors of suicidality and explained 15% of variance in suicidality, though depressive severity was the only significant predictor. Greater pain and narcotic use was also associated with depressive severity, and increased suicidality was associated with other medical comorbidities and childhood onset IBD. “Depressive severity is most associated with disease activity and QOL while suicidality is most associated with depressive severity and less so with IBD activity,” Chedid said. “It is worthwhile to screen your patients with IBD for depression and suicidality … to improve the quality of care that’s provided. “And remember, suicide is preventable,”

cause. I know my dad would be pleased to see me stepping so fantastically far out of my

Over the course of 2 months, Chedid and

comfort zone to achieve this. My family is really

colleagues prospectively studied 465 IBD

proud but I’m sure they will have much fun and

patients (mean age 44 years; 93% white;

hilarity watching me train!”

60% women; 65% with Crohn’s disease [CD];

he added. For more information:

32% with ulcerative colitis [UC]; and 3% with

Chedid V. O-006. Presented at: 2014 Advances

The trek is also inspired by Dr McCune’s

indeterminate colitis) at their outpatient IBD

in Inflammatory Bowel Diseases, Dec. 4-6,

work at Spire The Glen Hospital Bristol, where

clinic in order to identify rates and predictors

2014; Orlando, Fla.

Gastroenterology Today - SPRING 2015

On taking on the charity desert trek, Dr

and obtained data on patient demographics,

NEWS Naloxegol approved for marketing throughout European Union

(LOS) were performance of orthostatics

“There is a large variation in the process

in patients with normal vitals, placement

of care among institutions for acute

of large-bore IV lines, and appropriate

gastrointestinal bleeds,” Dr. Nordstrom

deployment or non-deployment of

said. He suggested that these data provide

hemostasis, said Carl Nordstrom, MD, chief

evidence that the quality indicators could at

The European Commission has granted

GI fellow in the University of California,

least reduce hospital stays, if not improve

Los Angeles’ integrated gastroenterology

overall outcomes in gastrointestinal (GI)

training program. The work was led by

bleeds, but cautioned that these findings

Brennan M. Spiegel, MD, director of

“should be confirmed in a prospective

laxatives, according to a press release.

the Center for Outcomes Research and

study.”

Naloxegol (Moventig, AstraZeneca) is the

in Los Angeles.

marketing authorization to naloxegol for the treatment of opioid-induced constipation in adult patients with inadequate response to

first once-daily oral peripherally-acting mu-

Education at Cedars-Sinai Medical Center, Using quality indicators to guide improved care is a growing phenomenon. In Of 26 quality indicators that were

colonoscopy, for example, some third-party

considered, adherence to eight was

payors are considering documentation of

evaluated, according to Dr. Nordstrom, who

quality indicators, such as an endoscope

“Constipation is one of the most common

presented the findings at Digestive Disease

withdrawal time of at least six minutes, for

side effects for those using opioid pain

Week 2014 (abstract 330). In addition to

reimbursement. In managing GI bleeds,

medication,” Briggs Morrison, executive

the four indicators most closely associated

however, Dr. Nordstrom said prospective

vice president of global medicines

with LOS, these included appropriate

evidence is needed to show that adhering

development and chief medical officer for

documentation of nasogastric lavage

to such indicators affects outcomes.

AstraZeneca, said in the release. “We’re

findings, admission of hypovolemic patients

very pleased to have received marketing

to an ICU, endoscopy within 24 hours and

James Scheiman, MD, professor of

authorization for Moventig, as it allows us to

use of a large-bore therapeutic endoscope.

gastroenterology at the University of

opioid receptor antagonist approved in the European Union, the release said.

Michigan, in Ann Arbor, said it is critical to

offer a new treatment option for the millions of patients across Europe who suffer from

The patients in the study were treated

demonstrate that establishing these kinds

opioid-induced constipation and haven’t

over a 10-year period (1996-2007) at a

of processes of care actually changes

responded to laxatives.”

single Veterans Affairs medical center. The

physician behavior.

average age was 63 years, and the average This approval follows data from the four

hospital LOS was 7.5 days. The average

“Is it that quality indicators matter or

studies included in the KODIAC clinical

number of serious comorbidities was 3.3 as

do better doctors do better with quality

program: two 12-week placebo controlled,

calculated with the Charlson Comorbidity

indicators?” he asked. He expressed

double-blind safety and efficacy trials, a 12-

Index. In the index hospitalization, to which

concern about “pop up” reminders in

week safety extension and a 52-week open

this analysis was confined, nearly 10% of

electronic medical record systems calling

label, long-term safety study.

the patients rebled, and 6.6% died.

for physicians to perform quality measures

Naloxegol was recently approved by the

In general, the greater the number of quality

FDA on September 16, 2014.

indicators met, the shorter the hospital

Improving processes of care must be

stay, the researchers found. This included

aligned with incentives in an integrated

For Acute GI Bleeds, Hitting Care Metrics Cuts Hospital Stays

a significant difference in the average stay

health care system that both encourages

between those in whom a single quality

and facilitates physicians to adhere, Dr.

indicator was met and those without any

Scheiman said. Goals must be realistic. He

documented quality indicators (6.5 vs. 10

noted that endoscopy within 24 hours was

days; P=0.003). Although the difference for

one of the quality indicators in the latest

In patients with acute gastrointestinal

those in whom four to six quality indicators

study, but it was only achieved about half

bleeding, meeting quality-of-care indicators

were achieved was only marginally better

the time, even in a center with a protocol for

reduces length of stay in the hospital, a

than for those with one to three, the average

handling acute gastrointestinal bleeding.

study has found.

stay for those in whom all eight quality

not yet proven to affect outcomes.

Gastroenterology Today - SPRING 2015

indicators were met was only four days.

Quality indicators are useful and have the potential to improve outcomes while

The retrospective study, involving 700 patients, is consistent with a series of other

The researchers found no association

reducing cost, Dr. Scheiman added, but

initiatives suggesting that adhering to and

between quality indicators and a patient’s

their real value emerges “if we can get

documenting quality indicators improves

risk for death, but incremental increases in

people who are not very good at this to do

outcome in gastroenterology practice.

the number of quality indicators performed

it better.”

were linked to a substantial reduction in the The quality indicators most significantly

need for a second endoscopy in addition to

associated with a reduced length of stay

the reduction in LOS.

>>>

NEWS Bile Acid Malabsorption Seen as Major Unrecognized Cause of Diarrhea in Cancer Patients Chicago—Poor absorption of bile acid is the cause of chronic diarrhea in a large proportion of cancer patients, new research shows. The study of 506 patients with diarrhea and a variety of cancer types found that 43% had bile acid malabsorption (BAM), suggesting an opportunity to substantially improve quality of life in patients with this complication. Characterized as a “landmark with significant patient numbers,” the study provides the basis for a more focused approach to complaints of diarrhea in patients with cancer, said Frank Phillips, MD, a trainee gastroenterologist at the Royal Marsden Hospital, in London, England, who presented at Digestive Disease Week 2014 (abstract 318). Led by Jervoise Andreyev, MD, PhD, a consultant gastroenterologist at the Royal Marsden Hospital, this was not the first study to associate BAM with diarrhea in this patient population, but the new data indicate that it has been an underappreciated source of the problem. In the study, patients referred to the clinic with chronic diarrhea were tested with selenium homocholic acid taurine (SeHCAT). SeHCAT is a radiolabeled bile acid analog that is readily measured with a gamma camera without the need to collect stool samples. Of the 506 patients referred over a four-year period, 34% had urologic cancers, 31% had cancers of the upper or lower gastrointestinal tract, 25% had gynecologic

Rates of BAM were particularly high in patients with cancers involving the upper pelvis. Among urologic malignancies, for example, BAM was more common in cancer of the bladder (50%) than the prostate (22%). In gynecologic

medicine in the Division of Gastroenterology and

suspected because dysfunction of the terminal

Hepatology at Mayo Clinic, in Scottsdale, Ariz.,

ileum is a well-established cause of BAM.

agreed that the limited availability of a diagnostic test for BAM is a significant problem for patients

High rates of BAM also were observed in

with cancer-related diarrhea or another reason.

patients with pancreatic cancer, particularly

He cited encouraging results with measurement

after a Whipple procedure, which can damage

of 7 alpha-hydroxy-4-cholesten-3 one, also called

the bile duct and lead to adverse changes

plasma C4 levels, which have correlated with

in bile metabolism. BAM was particularly

SeHCAT in some initial studies, but he cautioned

common in patients with hematologic

that this diagnostic test remains limited to the

malignancies and diarrhea. In this case,

research setting so far.

treatment with lenalidomide, which has been associated with altered bile acid metabolism,

Testing BAM with a therapeutic trial “seems

is a suspected cause.

reasonable,” but Dr. DiBaise remained cautious. Although he agreed that it might be

Far lower but still clinically meaningful rates

the best option given the current lack of other

of diarrhea were observed in other forms of

choices, he suggested that a response to bile

cancer, such as breast and lung. Testing for

acid sequestrants may be best characterized

BAM may still be justified even in these groups

as “supportive evidence” for BAM as a cause

when other causes of chronic diarrhea have

in patients with diarrhea.

been ruled out, Dr. Phillips said. “Use of bile acid sequestrants is often poorly In the United States, however, SeHCAT is not

tolerated and the response variable,” Dr. DiBaise

available. Stool analysis is an option, but many

said. “I find it difficult to strongly recommend this

strategy without a definitive diagnosis or at least patients do not like collecting and submitting stool GastroToday_Feb2015_29/01/2015 11:10 a very high index of suspicion.” samples. The next best option may be an empiric course of bile acid sequestrant. Several are available and an improvement in symptoms provides strong evidence of the underlying etiology. Although Dr. Phillips said he preferred a definitive diagnosis, relief of symptoms is the major goal. “Control of BAM to relieve chronic diarrhea improves quality of life and can prevent interruptions in cancer therapy,” Dr. Phillips said. He strongly

cancers, the same was true for tumors

recommended

involving the endometrium (42%) relative

greater attention to

to vulvovaginal tissues (less than 20%). For

BAM as a potential

gastrointestinal cancers, BAM was identified

etiology in cancer

more frequently in those with disease of the

patients with this

lower tract (50%) than of the upper (35%).

complaint.

Chemotherapy may sensitize the terminal ileum

John K. DiBaise,

to damage from radiation, according to

MD, professor of

Gastroenterology Today - SPRING 2015

cancers and the rest had other cancers.

Dr. Phillips. The role of this collateral damage is

NEWS Antidepressants benefited Gastroenterology publishes patients with functional landmark data from RESPECT oesophageal disorders, GERD study of Transoral Incisionless Fundoplication procedure Antidepressants modulate oesophageal sensation and reduce functional chest pain and are beneficial for patients with GERD, according to a recent systematic review. http:// dx.doi.org/10.1016/j.cgh.2014.06.025 Aiming to determine the utility of antidepressant therapy for symptoms of oesophageal visceral hypersensitivity associated with functional oesophageal disorders and GERD, researchers performed a comprehensive search of databases for relevant literature published from 1966 to February 2014. Eligible studies included one abstract, two case reports and 15 randomized, placebo-controlled clinical trials reporting the effects of tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors on experimentally induced oesophageal sensation and intensity/frequency of heartburn, chest pain, dysphagia or globus. The reviewed data demonstrated that oesophageal pain thresholds increased by 7% to 37% after antidepressant therapy. Furthermore, antidepressants reduced functional chest pain by 18% to 67% and reduced heartburn in patients with GERD by 23% to 61%. No data were available for patients with functional heartburn or functional dysphagia.

Gastroenterology Today - SPRING 2015

“In summary, the results of the trials included in this systematic review provide modest evidence that both TCAs and SSRIs modulate oesophageal sensation and reduce functional chest pain,” the researchers wrote. “Limited evidence suggests that SSRIs are beneficial for patients with heartburn, physiological acid exposure, and positive symptom association. Most importantly, this review emphasizes the lack of controlled trials investigating the effect of antidepressants on other oesophageal symptomatic disorders.” Despite its limitations, this study warrants future research on currently available antidepressants, non-antidepressant pain modulators and new oesophageal pain modulators, according to an accompanying editorial written by Carla Maradey-Romero, MD, and Ronnie Fass, MD, both from the Oesophageal and Swallowing Center and MetroHealth Medical Center at Case Western Reserve University in Cleveland. “Antidepressants are likely to remain the mainstay of treatment of functional oesophageal disorders and oesophageal disorders with a functional component despite limited evidence from well-designed clinical trials for their efficacy,” they wrote. “Lack of evidence owing to a paucity of clinical trials may not be interpreted as a lack of efficacy of these drugs.”

Both groups of patients enrolled in the RESPECT study, and their caregivers, were blinded to therapy during follow-up which occurred at two, 12 and 26 weeks. At the six month follow-up, all patients were un-blinded and the sham control patients were given the opportunity to have a TIF procedure.

Significantly More TIF/Placebo Patients Experienced Elimination of Troublesome Regurgitation as Compared to Sham/PPI Patients

Interferon-free Combination Therapy Can Prevent Posttransplant HCV Recurrence

EndoGastric Solutions (EGS) announces that Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute, has published landmark data from the first-ever blinded, randomized, sham- and placebo-controlled clinical study of the Transoral Incisionless Fundoplication (TIF®) procedure.

Following 2 recent studies published in Gastroenterology, researchers reported that a 24-week course of sofosbuvir and ribavirin could eliminate hepatitis C virus (HCV) infection in two-thirds of patients who undergo liver transplantation.

Of the 87 patients who were randomly assigned to the group that underwent the TIF procedure and then received an on-going course of placebo medication, after six months 67% reported elimination of troublesome regurgitation per Montreal consensus criteria. Meanwhile, of the 42 patients who were randomized to undergo sham surgery and then continued to take optimized doses of proton pump inhibitor (PPI) regiment (omeprazole), 45% reported elimination of the same symptom (p=0.023). “Consistent with the Montreal definition, the RESPECT (Randomized EsophyX® vs. Sham/ Placebo Controlled Trial) study enrolled patients with troublesome regurgitation and objectively confirmed gastroesophageal reflux disease (GERD). This is the first ever randomized blinded trial to focus exclusively on regurgitation,” said John Hunter, MD, Mackenzie Professor & Chairman of Surgery, Oregon Health & Science University and co-principal investigator. “The data demonstrates that the TIF procedure is more effective than optimized PPI drugs at eliminating troublesome regurgitation in selected chronic GERD patients with hiatal hernia less than 2 cm,” continued Dr. Hunter. In addition, 77% of the TIF patients had healed their reflux esophagitis. TIF procedure was also associated with a decrease in all acid exposure parameters while patients in the control group had no detectable improvements in pH control (p<0.001). “In other studies, the therapeutic gain of PPI therapy over placebo for the control of regurgitation is modest. Data from this well designed study suggest that the TIF procedure provides an attractive option to manage troublesome GERD symptoms, especially considering a notable absence of troublesome dysphagia and bloating after the TIF procedure,” said Peter Kahrilas, MD, Professor of Medicine-Gastroenterology, Northwestern University and co-principal investigator.

The initial study, a Phase 2, open-label procedure observing 61 HCV patients reported that up to 48 weeks of combination therapy with sofosbuvir and ribavirin before liver transplantation could prevent recurrence of HCV infection posttransplantation in 70 percent of patients. Michael P. Curry, MD, Beth Israel Deaconess Medical Center, Boston, MA, said, “Patients with hepatitis C virus at the time of liver transplantation universally experiences recurrent HCV infection. Recurrent HCV infection follows an aggressive course. Given the burden of disease – the increased morbidity, mortality and costs – and the lack of a safe and broadly effective treatment to prevent recurrence of HCV infection, these results provide hope for patients in need.” The second clinical trial, a prospective, multicenter, open-label pilot study, included patients with recurrent HCV infection following a primary or secondary liver transplant. These set of patients were administered an all-oral regimen of sofosbuvir and ribavirin for a 24-week period, which spurred a sustained virologic response, with no detectable virus, in 70 percent of the patients. Both studies shared lowrates of discontinuation as a direct result of adverse events. According to Michael R. Charlton, MD, Mayo Foundation, Rochester, MN, it was found that, “A well tolerated and effective treatment protocol for recurrence of HCV infection following liver transplantation is an important unmet clinical need. Our study demonstrates that patients with characteristics that have historically been difficult to cure with interferon-based regimens, including those with advanced disease, may benefit from this all-oral interferon-free therapy.” - See more at: http://www.hcplive.com/ articles/Interferon-free-CombinationTherapy-Can-Prevent-Post-transplant-HCVRecurrence#sthash.J9rFLRAv.dpuf

NEWS than current therapies, even in traditionally

a biomarker assay to direct the clinical

hard-to-cure patients.

management of Barrett’s oesophagus.

Significant diagnostic technique developments

This year saw record numbers of abstracts

were revealed in a presentation on the

being submitted and the Scientific Committee

UEG Week is the largest and most prestigious

results from a large study aimed at improving

selected the following five Top Abstract

gastroenterology meeting of its kind in Europe

surveillance programmes in the treatment of

winners: Dr Michael Sigal from Stanford

and has developed into a global congress.

nondysplastic Barrett’s Oesophagus using

University School of Medicine, Dr Takahisa

With 13,000 delegates from 118 countries

fluorescent in situ hybridisation (FISH). The

Matsuda from the Tokyo National Cancer

attending, this year’s 22nd UEG Week in

study included 428 patients with nondysplastic

Center Hospital, Dr Gitta Maria Seleznik of

Vienna was a resounding success.

BO and the authors showed that patients

Universitätsspital Zürich and Drs Lidewine

who were marker positive have a significantly

Daniels and Jochem Huib Jan Bernink from

Advancing the path of innovation and world

higher annual risk of progression to high-grade

the Amsterdam Academic Medical Center.

class research, the 2014 congress saw

dysplasia/oesophageal adenocarcinoma

cutting-edge post-graduate teaching sessions;

than marker-negative patients. According to

presentation of new research and thinking

a multivariate proportional hazards model, a

across a wide range of digestive disease

positive FISH result is a significant predictor

areas; the introduction of E-poster terminals;

for disease progression. These results indicate

the highly interactive ‘Posters in the Spotlight’

that molecular markers could be useful in

sessions and hi-tech simultaneous live

clinical practice for stratifying patients with non-

streams to a global audience.

dysplastic BO into low- and high-risk categories,

UEG Week, Vienna 2014: Highlights

and identifying those patients who would Many exciting advances in GI healthcare

eventually progress to cancer, thus requiring

provision are presented every year at UEG

inclusion in aggressive surveillance programmes.

Week and I am pleased to share my personal highlights of treatment discoveries and

An abstract presentation from a Japanese

advances in diagnostic techniques from this

multicentre study on the follow-up of patients

year’s congress.

after endoscopic resection of colonic adenomatous lesions was also an important

GI treatment advances and diagnostic

paper to help streamline diagnostic provision.

developments

This paper clearly shows that after obtaining

Amongst the presentations focusing on

a ‘clean’ colon with polypectomy, after two

treatment advances, were new biologic

colonoscopies performed at 1-year intervals,

treatments for inflammatory bowel disease

there is no reason to perform a follow-up

(IBD), ‘Therapy update: Best use of biologics

colonoscopy before 3 years. The burden of

in IBD in 2014’ and, from my own area

follow-up colonoscopies at inappropriate time

of expertise, ‘Viral Hepatitis C: Optimal

intervals is one of the major issues of work

management today and in the near future.’

overload in many Western endoscopy units and this data should reassure patients of their

UEG’s Pan-European Survey of Digestive Health and Healthcare in 2040: Scenarios and Implications UEG’s major pan-European survey of digestive health was also launched at the week. It highlights the burden of gastrointestinal (GI) disorders as well as variances in incidence and mortality rates. The survey also provides details of the changing trends and inequalities in many GI and liver diseases and the provision of healthcare services across the continent. The ‘Healthcare In Europe 2040’ – a series of scenarios as to what the future of healthcare might look like in Europe in 2040 formed a key focus for UEG Week. This initative aims to encourage discussion, debate and future planning amongst policy makers and the gastroenterologist community. It will be interesting to see which scenario the GI community regards the most likely and how this will shape the future of digestive health. Professor Michael P. Manns MD, UEG Vice President, Chairman, Department

The session exploring new biologic treatments

actual risk of developing new adenomatous

for IBD and many of the Free Paper abstracts

lesions. Secondly, it shows how accurate our

submitted to UEG Week this year herald an

Japanese colleagues can be in the recognition

exciting new era in the treatment of IBD in

and removal of non-polypoid lesions, which

daily clinical practice. Not least is the potential

are most probably at the origin of many right-

for therapeutic drug monitoring – early

sided interval cancers in Western countries.

measurement of drug and anti-drug antibody

High quality colonoscopy has become a must

translational research and numerous scientific

concentrations – to help define primary non-

in our daily practice and every educational

cooperations. As one of Europe’s most cited

response or secondary loss of response to

effort should be made to improve our

scientist he has published more than 10,00

biologic therapies and guide decision-making.

diagnostic and therapeutic capabilities.

groundbreaking publications in the field of liver,

of Gastroenterology, Hepatology, and Endocrinology, Hannover Medical School, Germany

gastric and intestinal diseases. He is been Regarding Viral Hepatitis C treatment

Research Prize and Top Abstract Awards

the chairman of the Collaborative Research Center SFB 738 “Optimization of conventional

advances, data was presented concerning several new pill-only regimens that rapidly

The UEG Research Prize was awarded to

and innovative transplants”, funded by the

cure most patients with genotype 1 hepatitis

Professor Rebecca Fitzgerald, University

German Research foundation DFG since 2007.

C (HCV) infection which could soon be widely

of Cambridge, United Kingdom, for her

He is also the Co-Coordinator of the research

prescribed across Europe. These new pill-only

pioneering work in early detection methods for

center TR77 “Liver Cancer - from molecular

regimens have the potential to offer more

oesophageal cancer. Professor Fitzgerald’s

pathogenesis to targeted therapies” and chair

effective, safer and faster virus eradication

award will support her work to develop

of the German Liver Foundation.

Gastroenterology Today - SPRING 2015

Professor Manns is renowned for his

FEATURE

No Correlation between the Month of Birth and the Likelihood of Developing Inflammatory Bowel Disease Later in Life E. M. De Boer1, M. A. Brink2, M. H. M. G. Houben3, A. H. A. M. van Oijen4, W. A. De Boer5* Leids Universitair Medisch Centrum, Leiden, The Netherlands, 2Meander Medisch Centrum, Amersfoort, The Netherlands 3 Haga Teaching Hospital, The Hague, The Netherlands, 4Medisch Centrum Alkmaar, Alkmaar, The Netherlands 5 Bernhoven Ziekenhuis, Uden, The Netherlands Email: *w.deboer@bernhoven.nl Copyright © 2014 by authors and Scientific Research Publishing Inc. This work is licensed under the Creative Commons Attribution International License (CC BY). http://creativecommons.org/licenses/by/4.0/ 1

Abstract Background: The etiology of Crohn’s disease (CD) and Ulcerative Colitis (UC) remains unclear. It has been suggested that apart from genetic factors, prenatal or perinatal environmental factors could change the risk of developing inflammatory bowel disease (IBD) later in life. Seasonality in birth distribution over the year has been demonstrated for several immune diseases, but studies on IBD have had inconsistent results. Aim: The aim of this study was to investigate in the Netherlands the effect of the month of birth on the probability to develop IBD later in life. Methods: Birth data from CD patients and UC patients of 4 different Dutch hospitals were compared to a control group of irritable bowel syndrome (IBS) patients from the same hospitals. A chi-square test was used to test whether there was heterogeneity between the monthly and seasonal birth rates of the three groups. Results: The patient cohort consisted of 1183 CD patients and 1293 UC patients. The control group consisted of 2113 IBS patients. Data showed no difference in birth distribution over the year or over the four seasons of IBD patients as compared to the control group. P-values over the year and over the seasons respectively are 0.428 and 0.237 for CD and 0.311 and 0.812 for UC. Conclusions: There is no seasonality in the distribution of births of IBD patients as compared to controls. The hypothesis that environmental factors present at the time of birth play a role in the pathogenesis of IBD is not supported by these data. Gastroenterology Today - SPRING 2015

Keywords: Inflammatory Bowel Disease; Season; Seasonality; Month; Birth; Crohn Disease; Colitis Ulcerative

*Corresponding author.

1. Introduction

The immune system of a newborn baby is shaped and conditioned by the exposure to antigens from its environment. It is conceivable that these earliest contacts between the innate immune system and the viruses and bacteria that it encounters can shape the immune system in a certain direction. It is also conceivable that a baby born in the winter is primarily exposed to a different set of infections, or antigens as compared to a baby born in the summer. In this way these earliest antigenic contacts of the immune system may mold the immune system more or less in a similar form. This may then, later on in life, translate into a susceptibility to acquire a certain disease or on the other hand into protection to acquire a disease. A second hypothesis is that the gut flora is established in the first weeks of being outside the uterus and it is conceivable that the initial gut microbiota of a baby born in winter may therefore differ from the initial microbiota of a baby born in summer. This may explain why the month of birth could predispose an individual to IBD [3]. This proposed cyclic variation in the birth pattern of patients is called “seasonality” and is not unique for IBD alone. Similar correlations have been documented for other diseases in which the immune system or auto-immunity is a crucial factor in the etiology of the disease such as diabetes type I and asthma [4] [5]. Therefore previous studies have sought a relationship between the month, or season of birth and the risk of developing IBD later in life. However, outcomes of these studies differed substantially [2] [6] - [16]. So far no such study was done in the Netherlands. Since earlier studies are inconsistent and there is a lack of data from the Netherlands, this study aimed to examine the effect of the month of birth on the probability to develop IBD later in life in a Dutch population. We compared birth data from a large cohort of IBD patients with a control group that consisted of IBS patients from the same geographic region.

IBD is characterized by chronic, recurrent inflammation of the Gastro Intestinal (GI) tract. CD can affect any component of the gastro-intestinal tract, although it mostly affects the terminal ileum, whereas UC is strictly limited to the colon. CD and UC have distinct pathologic and clinical characteristics, however the precise etiology and pathogenesis for both diseases are still unclear [1].

2. Methods

It has been suggested that, next to genetics, prenatal or perinatal environmental factors could change the risk of developing inflammatory bowel disease later in life [2].

For this study, data from 4 different hospitals in different geographical areas of the Netherlands were used. These hospitals were: Bernhoven HospitalOss, Meander MC-Amersfoort, MC Alkmaar (MCA), and Haga Teaching

FEATURE Hospital-Den Haag (Haga). Gastroenterologists in the Netherlands are all

There was no difference in distribution of months of birth over the year

working in specialty groups that are based in a hospital. In the Netherlands

between patients with IBD and the control group. Table 3 and Table

there is a uniform registration and billing system for medical diagnosis

4 show the expected and observed birth rates in every month of the

(Diagnose-Behandel-Combinatie (DBC)). Patients were considered to suffer

year for 1183 CD patients and 1293 UC patients respectively. P-values

from IBD when they were entered in the hospital billing system with DBC

are 0.428 and 0.237. Nor was there any difference when the expected

registration code 601 (CD) or 602 (UC), controls were all patients from the

and observed birth rates for the four different seasons of the year are

same hospital with DBC code 205 (IBS).

compared between IBD patients and the control group. P-values are 0.311 for CD patients and 0.812 for UC patients. This is shown in Table

The medical diagnosis as registered in the DBC system is a very reliable

5 and Table 6. Based on these data a specific month of birth, or birth

source for patient data and epidemiology since we can be sure that

in one of the four seasons, is not a risk factor for developing CD or CU

a patient with a certain DBC code is indeed being diagnosed with the

later in life.

disease that is registered in the system. There were no other specific inclusion of exclusion criteria; all patients with the right DBC diagnostic code from the 4 hospitals were included. From the patient data in the DBC billing system only the date of birth and the gender of the patient were obtained. 2.1. Ethics In the analysis no patient identifiers were used. According to Dutch law this study did not require approval from an institutional medical Ethic Board because only date of birth and gender of patients were revealed to the investigator. 2.2. Statistical Analysis The rates of births per month in a population are not evenly distributed over the year, for example in 2010 more children in the Netherlands were born in the months July, August, September and October [17]. We therefore need a control group which represents the true distribution of births over the year. Patients with irritable bowel syndrome served as a control group in this study. In order to test whether there was

4. Results In this largest study to date we found no role for seasonality in the pathogenesis of IBD. We used birth data obtained from the Dutch billing system for gastroenterologists to investigate the monthly and seasonal variations in month of birth among patients with CD and UC. For this study data were collected from four different hospitals in various regions of Holland. This makes the data representative for the whole country and it reduces the probability of selection bias. Furthermore the unaffected control population was selected from the same hospitals and therefore originated from the same geographical area. Our data show no deviation from an expected distribution in birth rates over the year in IBD patients as compared to a control group of IBS patients. These findings suggest there is no seasonal pattern in the risk to develop either CD or CU in the Netherlands. Table 1. Numbers of patients from four different hospitals.

heterogeneity (a significant deviation from an expected distribution) Crohn’s Disease

Ulcerative Colitis

Control Group

Total

Bernhoven N (%)

204 (25.2)

198 (24.5)

406 (50.2)

808 (100)

MCA N (%)

255 (17.2)

352 (23.8)

872 (59.0)

1479 (100)

Haga N (%)

421 (30.9)

408 (30.0)

532 (39.1)

1361 (100)

Meander MC N (%)

304 (24.3)

342 (27.4)

603 (48.3)

1249 (100)

between the months and seasons of birth we used the chi-square test. Birth data from the control group were used to calculate expected rates of births per month. The observed monthly rates of birth during the year in patients with CD and UC respectively were compared to the calculated expected rates. Secondly, seasonal birth rates were compared. Four clusters of three months were used to define the different seasons: spring (March, April, May), summer (June, July, August), autumn (September, October, November), winter (December, January, February).

performed using IBM® SPSS® Statistics software, version 18. Differences

Table 2. Baseline characteristics.

were considered to be statistical significant with P-values < 0.05.

3. Results The study population consisted of 2476 IBD patients: 1183 CD patients, 1293 CU patients and a control group of 2113 irritable bowel syndrome patients. Patient numbers and the percentages of CD, UC and IBS patients from the different hospitals are shown in Table 1. The baseline characteristics were not significantly different between the groups,

Mean age (years) Sex (%) Male Female

Crohn’s Disease (N = 1183)

Ulcerative Colitis (N = 1293)

Control Group (N = 2113)

P-Value

Crohn: 0.18 Colitis: 0.56

34.2% 65.8%

48.7% 51.3%

31.1% 68.9%

Crohn: 0.66 Colitis: 0.90

although patients in the control group were slightly older. Also, CD patients and IBS patients were mostly female whereas this gender distribution was fifty-fifty in UC patients. These data are shown in Table 2.

Gastroenterology Today - SPRING 2015

The Database with birth dates and genders of the patients was built and managed with Microsoft® Excel software. All statistical analysis was

>>> 13

FEATURE Table 3. Observed vs. expected rates of birth for every month in 1183

Table 5. Observed vs. expected rates of birth for every season in 1183

patients with Crohn’s disease.

Months of the year

Observed Number

Expected Number

Season

Observed Number

Expected Number

January

98 =

109.8

Spring

294 ↓

322.5

February

99 ↑

88.5

Summer

318 =

304.5

March

89 ↓

109.8

Autumn

279 =

274.3

April

96 =

104.1

Winter

292 =

281.7

May

109 =

108.6

χ2 (3 d.f.)

3.573

June

99 =

94.6

P-value

0.311

July

105 =

101.9

August

114 =

108.0

September

108 ↑

96.3

October

92 =

93.0

Season

Observed Number

Expected Number

November

79 =

85.1

Spring

343 =

352.5

December

95 ↑

83.4

Summer

335 =

332.8

χ2 (11 d.f.)

11.184

Autumn

313 =

299.9

P-value

0.428

Winter

302 =

307.9

χ2 (3 d.f.)

0.957

P-value

0.812

Table 4. Observed vs. expected rates of birth for every month in 1293 patients with ulcerative colitis.

Gastroenterology Today - SPRING 2015

Months of the year

Observed Number

Expected Number

January

115 =

120.0

February

90 =

96.7

March

137 ↑

120.0

April

106 =

113.8

May

100 ↓

118.7

June

110 =

103.4

July

125 ↑

111.3

August

100 ↓

118.0

September

104 =

105.2

October

102 =

101.6

November

107 ↑

93.0

December

97 =

91.2

χ (11 d.f.)

13.926

P-value

0.237

Previous studies have had contradictory results. A very large population study from the United Kingdom (UK) found no seasonality in the birth dates of IBD patients, which is in line with our data [12]. A second paper from the UK (N = 1624) found a weak association with being born in the first half of the year and developing Crohn’s disease [6]. An older study (N = 2175) from Sweden showed clustering of births from IBD patients during spring. This was more pronounced for CD than for UC [2]. The same outcomes were recently found in a case-control study from Canada (N = 11145). A study from Israel (N = 844) found a significant seasonality in birth dates of CD patients: birth during the winter period was associated with a reduced risk of developing CD and birth in the summer period was associated with an increased risk. No such clustering of births was found in UC patients [9]. A more recent Chinese study (N = 409) showed that the birth rates of UC patients were higher in the autumn-winter period than in the spring-summer period, which is in line with a Korean study (N = 727) that was published lately [13]. Furthermore a study from Belgium (N = 1025) showed only significant results for the month June: individuals born in this month had a reduced risk of developing CD later in life [10]. Three studies investigated the season of birth and childhood IBD [7] [8] [11]. One Danish study showed a peak in birth dates in August and a trough in March, the second one, a British study, didn’t found any seasonality effect, and in the last study from Slovakia most children that developed IBD were born between June and October and least were born between December and March [7] [8] [11]. Although, as described above, some previous studies have suggested that a relationship between the month of birth and the likelihood of

>>> 14

Table 6. Observed vs. expected rates of birth for every season in 1293 patients with ulcerative colitis.

developing disease later in life does exist these data are inconsistent and contradictory in their findings. If there was true seasonality for IBD

FEATURE 20 Year Olds. Gut, 51, 814-815. http://dx.doi.org/10.1136/ gut.51.6.814

patients, one would expect positive studies would all show a similar pattern, and this is not the case. However the summer months in the northern hemisphere are the winter months in the southern hemisphere and there are a lot of different climate zones all over the world. Furthermore none of the studies reflects whether the seasons of the consecutive years that were studied were typical or hotter/colder than normal. These can all be reasons for the inconsistency of the outcomes of the previously conducted studies. Also, the number of patients in all of these studies differed and the observed effects might have occurred by chance alone. On the other

[9]

Chowers, Y., Odes, S., Bujanover, Y., Eliakim, R., Bar Meir, S. and Avidan, B. (2004) The Month of Birth Is Linked to the Risk of Crohn’s Disease in the Israeli Population. American Journal of Gastroenterology, 99, 1974-1976. http://dx.doi.org/10.1111/j.15720241.2004.40058.x

[10] Van Ranst, M., Joossens, M., Joossens, S., Van Steen, K., Pierik, M., Vermeire, S. and Rutgeerts, P. (2005) Crohn’s Disease and Month of Birth. Inflammatory Bowel Disease, 11, 597-599. http:// dx.doi.org/10.1097/01.MIB.0000163697.34592.d4

hand when the effect size is small there is a chance of type II errors in studies with small sample sizes. The present study, with 2476 IBD patients (1183 CD patients, 1293 UC patients), investigates one of the largest IBD patient cohorts of all studies yet and its result are therefore probably more robust.

5. Conclusion In summary, the present study shows that babies born in certain months or seasons of the year do not have a higher risk of developing IBD later in life in the cohort. Based on our result we conclude that in the Netherlands seasonality plays no role in the pathogenesis of IBD.

References [1]

Xavier, R.J. and Podolsky, D.K. (2007) Unravelling the Pathogenesis of Inflammatory Bowel Disease. Nature, 448, 427434. http://dx.doi.org/10.1038/nature06005

[2]

Ekbom, A., Zack, M., Adami, H.O. and Helmick, C. (1991) Is There Clustering of Inflammatory Bowel Disease at Birth? American Journal of Epidemiology, 134, 876-886.

[3]

Shaw, S.Y., Blanchard, J.F. and Bernstein, C.N. (2011) Association between the Use of Antibiotics and New Diagnoses of Crohn’s Disease and Ulcerative Colitis. American Journal of Epidemiology, 106, 2133-2142. http://dx.doi.org/10.1038/ajg.2011.304 Kahn, H.S., Morgan, T.M., Case, L.D., Dabelea, D., Mayer-Davis, E.J., Lawrence, J.M., Marcovina, S.M. and Imperatore, G. (2009) Search for Diabetes in Youth Study Group. Association of Type 1 Diabetes with Month of Birth among US Youth: The Search for Diabetes in Youth Study. Diabetes Care, 32, 2010-2015. http:// dx.doi.org/10.2337/dc09-0891

[5]

Gazala, E., Ron-Feldman, V., Alterman, M., Kama, S. and Novack, L. (2006) The Association between Birth Season and Future Development of Childhood Asthma. Pediatric Pulmonology, 41, 1125-1128. http://dx.doi.org/10.1002/ppul.20442

[6]

Haslam, N., Mayberry, J.F., Hawthorne, A.B., Newcombe, R.G., Holmes, G.K. and Probert, C.S. (2000) Measles, Month of Birth, and Crohn’s Disease. Gut, 47, 801-803. http://dx.doi.org/10.1136/ gut.47.6.801

[7]

Sørensen, H.T., Pedersen, L., Nørgård, B., Fonager, K. and Rothman, K.J. (2001) Does Month of Birth Affect Risk of Crohn’s Disease in Childhood and Adolescence? British Medical Journal, 323, 907. http://dx.doi.org/10.1136/bmj.323.7318.907

[8]

Card, T.R., Sawczenko, A., Sandhu, B.K. and Logan, R.F. (2002) No Seasonality in Month of Birth of Inflammatory Bowel Disease Cases: A Prospective Population Based Study of British under

[12] Sonnenberg, A. (2009) Date of Birth in the Occurrence of Inflammatory Bowel Disease. Inflammatory Bowel Disease, 15, 206-211. http://dx.doi.org/10.1002/ibd.20730 [13] Bai, A., Guo, Y., Shen, Y., Xie, Y., Zhu, X. and Lu, N. (2009) Seasonality in Flares and Months of Births of Patients with Ulcerative Colitis in a Chinese Population. Digestive Diseases and Sciences, 54, 1094-1098. http://dx.doi.org/10.1007/s10620-0080453-1 [14] Angelucci, E., Cocco, A., Cesarini, M., Crudeli, A., Necozione, S., Caprilli, R. and Latella, G. (2009) Monthly and Seasonal Birth Patterns and the Occurrence of Crohn’s Disease. American Journal of Gastroenterology, 104, 1608-1609. http://dx.doi. org/10.1038/ajg.2009.107 [15] Shaw, S.Y., Nugent, Z., Targownik, L.E., Singh, H., Blanchard, J.F. and Bernstein, C.N. (2014) Association between Spring Season of Birth and Crohn’s Disease. Clinical Gastroenterology and Hepatology, 12, 277-282. http://dx.doi.org/10.1016/j. cgh.2013.07.028 [16] Jung, Y.S., Song, C.S., Kim, E.R., Park, D.I., Kim, Y.H., Cha, J.M., Kim, J.H., Lee, S.H., Eun, C.S. and Han, D.S. (2013) Seasonal Variation in Months of Birth and Symptom Flares in Korean Patients with Inflammatory Bowel Disease. Gut Liver, 7, 661-667.

Gastroenterology Today - SPRING 2015

[4]

[11] Mikulecký, M. and Cierna, I. (2005) Seasonality of Births and Childhood Inflammatory Bowel Disease. Wiener klinische Wochenschrift, 117, 554-557. http://dx.doi.org/10.1007/s00508005-0391-2

POSTERS

Straight to test lower GI endoscopy: the Whittington Experience Thapar A, Rodney S, Haboubi D, Oshowo A, Bhan C, Wilson J, Walshe M, Haddow J, Mukhtar H

Colorectal Surgery Department, Whittington Hospital, London

Summary

CONCLUSIONS

Benefits

Limitations

A new nurse triaged straight to endoscopy pathway was introduced and was retrospectively audited in 2012-2013.triaging patients straight • • • •

to endoscopy following two week suspected c

Initial outpatient appointments saved in 80% of patients Reduction in 10 days to first treatment for colorectal cancers Quicker exclusion of cancer and peace of mind Follow-up appointments saved in 67% of those with a normal colonoscopy.

• Higher proportion with benign pathology referred as fast track • Increased work for the colorectal specialist nurse who ran the service • Greater demand on endoscopy unit

Background

• From August 2011 to July 2012 57% (24/43) of patients with suspected colorectal cancer took longer than 31 days to receive a treatment plan • 2/40 (5%) breached the 62 day referral to treatment target • If <85% of fast track referrals receive treatment within 62 days, up to 2% of total cancer revenue per month can be withheld

Aims • To reduce time to first oncological treatment • To apply lean methodology to minimise unnecessary outpatient visits

Methods • A new telephone triage service led by the colorectal specialist nurse was established, confirming symptoms and assessing fitness for colonoscopy, with higher-risk patients or those with equivocal symptoms defaulting to flexible sigmoidoscopy or clinic appointment.

Results 429 referrals were made to the colorectal specialist nurse who spent 110 hours triaging these patients. Between 2011-2012, 42 patients were diagnosed with colorectal cancer following a two week wait referral, compared with 14 the following year. Compared to the year before there was: • no significant difference in time to first hospital visit (p=0.62) for confirmed cancer patients • a trend towards a quicker time to treatment (p=0.01) in straight to test patients with confirmed cancer (median of 10 days saved) • A saving of 350 initial assessment appointments and 74 follow-up appointments overall

Time to treatment plan

Gastroenterology Today - SPRING 2015

Figure 1: Primary investigation. Time to first treatment 95% Colonoscopy Flexible sigmoidoscopy Outpatient appointment DNA their appointment

0 Benign

Malignant

Figure 2: Diagnoses of 358 patients who underwent lower GI endoscopy in 2012-13.

2011-2012

2012-2013

Figure 3: Median days to diagnosis and treatment.

Discussion • • • • •

Straight to lower GI endoscopy was achieved in 80% of fast track referrals Cancer was uncommon, reflecting the difficulties of primary care assessment and an ongoing need to verify symptoms pre-endoscopy The impact of the service was shifting work away from clinic to the colorectal specialist nurse and the endoscopy department 1/3 of new cancer patients still waited over a month for a treatment plan, reflecting staging investigations and MDT discussion. One 62 day breach still occurred in one elderly patient undergoing pre-assessment for anterior resection

The new system was suitable for 80% of patients and resulted in a small reduction in time to treatment. The main benefits were the number of colorectal clinic appointments freed to counsel and treat those with established pathology.

For the reliable and quick in vivo diagnosis for the gastro-duodenal presence of Helicobacter pylori. When to use Pylobactell 13 C-Urea Breath Test (UBT) Uninvestigated Dyspepsia Offer H pylori ‘test and treat’ to patients with dyspepsia1 Peptic Ulcer Disease Test to confirm before treating and to confirm eradication 6-8 weeks after commencement of treatment1

The UBT using [13C] urea remains the best test to diagnose H pylori infection, has a high accuracy and is easy to perform2 Precise – 98.3%3 and non-invasive Easy to use – can be performed at home or under the supervision of healthcare staff Highly sensitive and specific to Helicobacter pylori Breath samples analysed by a UKAS accredited testing laboratory, No. 2256

CO2 Breath

Simple and effective methodology: As a defence against local acidic conditions, Helicobacter pylori bacteria excrete urease which converts urea into carbon dioxide and ammonia. If a Helicobacter pylori infected individual is given 13C-labelled Urease in H.p. urea, the 13C is NH detected in the C=0 CO + NH NH breath CO2 30 minutes after ingestion.

CO2

CO2 Blood

Abridged Prescribing Information – Pylobactell® (13C-Urea): Presentation: Soluble tablet containing 100mg 13C-Urea. Uses: In vivo diagnosis of gastroduodenal Helicobacter pylori infection. Dosage and Administration: Adults: The tablet is to be dissolved in water and taken 10 minutes after the start of the breath test procedure. The patient should fast for at least 4 hours before the test so that the test is taken on an empty stomach. If the patient has eaten a heavy meal, then it will be necessary to fast for 6 hours prior to the test. Paediatric patients: Pylobactell is not recommended for use in children and adolescents below the age of 18 years due to insufficient data on efficacy. Contraindications: Hypersensitivity to the active substance or to any of the excipients. The test must be not be used in patients with documented or suspected gastric infection that might interfere with the urea breath test. Special Warnings and Precautions for Use: A positive urea breath test alone does not clinically confirm that eradication therapy is indicated. Alternative diagnosis with invasive endoscopic methods might be indicated in order to examine the presence of any other complicating conditions, e.g. gastric ulcer, autoimmune gastritis and malignancies. In individual cases of atrophic gastritis, the breath test result may have a false positive outcome and other tests may be required to confirm the presence of H. pylori. If a repeat test is required, it should not be carried out until the following day. For patients who do not tolerate the recommended test meal, an alternative test meal should be given. Care should be taken in patients where fasting may have medical implications. There are insufficient data on the diagnostic reliability of the Pylobactell test to recommend its use in patients with partial gastrectomy and in patients younger than 18 years. Side Effects: None known. Instructions for Use and Handling: Fasting (see dosage and administration). The patient should be in a seated position. T=0: Drink test meal, T=5 mins: Collect Pre-urea samples, T=10 mins: Drink dissolved PYLOBACTELL® tablet, T=40 mins: Collect Post-urea samples. Transfer spare bar code labels to patient’s notes and analysis request form. Seal box with the security label and send to a qualified laboratory for analysis. Legal Category: POM. NHS Price £20.75. Marketing Authorisation Number: EU/1/98/064/001. Marketing Authorisation Holder: Torbet Laboratories Ltd. Date of Preparation: August 2014. Information about this product, including adverse reactions, precautions, contra-indications and method of use can be found at www.cambridge-healthcare. co.uk/laboratory Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Torbet Laboratories Ltd 1 2 3

NICE Guidelines: Dyspepsia and gastro-oesophageal reflux disease: Guidelines [CG184] Published date: September 2014 Gisbert JP, Pajares JM.: 13C-urea breath test in the diagnosis of Helicobacter pylori infection—a critical review. Aliment Pharmacol Ther 2004;20:1001–17 ¹³C-urea breath test – a reliable diagnostic technique for assessment of eradication. Gut 1996: 39 (suppl 3): A37.

Torbet Laboratories Ltd., Unit 1 Chestnut Drive, Wymondham, Norfolk, NR18 9SB. Tel: 01953 607856 Fax. 01953 713649 E-mail: customerservices@torbetlaboratories.co.uk

2PYL12/1501b

POSTERS

Factors Inﬂuencing the Quality o North West

G Beejooa, N Pra Introduc<on Endoscopy is integral to the JRCPTB Gastroenterology Curriculum and the JAG clearly defines competencies that must be achieved before independent pracDce. Training in colonoscopy for Gastroenterology Specialty Trainees (ST) can be challenging due to current work paJerns and non-‐GI commitments. We aimed to evaluate the opportuniDes for and the quality of colonoscopy training in the NW Deanery as perceived by STs. Methods An electronic quesDonnaire was sent to all Gastroenterology STs enrolled within the NW Deanery including quesDons based on data which would be available from the JETS e-‐porPolio. STs were excluded at the point of entering OOP acDvity. To allow comparison, number of procedures performed was standardised to year of training and to length of Dme in each post. We used an arbitrary minimum expected number of procedures per year at each level of training to calculate adequacy of training opportuniDes. We proposed that an ST3 would complete 40 colonoscopies, an ST4 would complete 75 colonoscopies and ST5 and above would complete on average 100 colonoscopies per annum respecDvely. Results 29 trainees completed the survey (ST3=3, ST4=8, ST5=4, ST6=6, ST7=1, OOP=7) at 13 sites. 7 (24%) had achieved JAG accreditaDon for diagnosDc colonoscopy. Overall compleDon rate (CR) was 52.2% (0 to 97%). Mean number of colonoscopies (and independent CR) was: ST3=25.6 (7%), ST4=68.9 (19%), ST5=103.3 (65%), ST6=105.7 (87%), ST7=66 (92%). 5 (17%) STs had a CR of >90% and had performed an average of 270 procedures to aJain this level. Average terminal ileal intubaDon rate was 22.7% (0 to 67%). The average number of colonoscopies per year for each individual site ranged from 34% to 160% of expected procedures. 22 (76%) STs had used a scope guide and 52% found this useful or invaluable in their training. 2 trainees reported serious complicaDons of unplanned hospital admissions. 18 STs (62%) were primarily supervised by a Consultant. 62% of trainees were saDsfied with the level of supervision during endoscopy. 62% of trainers had completed a TCT course or equivalent but 14% of STs did not know this informaDon. The major limiDng factor affecDng colonoscopy training was GIM commitments (72%, 21) with lists missed due to on call shics. 41% (12) reported that training lists were not tailored to their needs, 38% (11) missed lists due to lack of ward cover and 38% (11) did not feel that they had enough colonoscopy lists. Other factors affecDng colonoscopy training included compeDDon with nurse endoscopists (14%, 4) and trainers taking over too early (10%, 3). 24% of STs rated their saDsfacDon with colonoscopy training at 4 or 5 (on a scale of 1 to 5, where 1 was poor and 5 was excellent).

Gastroenterology Today - SPRING 2015

Conclusions There is considerable variability in opportuni<es and quality of colonoscopy training in the NW Deanery. Service provision must be balanced with a structured, high quality training programme to ensure that colonoscopy performance can meet the mandatory standards expected at the <me of CCT. In our region, it is reassuring that STs seem to achieve these targets by ST7 despite the challenges we iden<ﬁed. This study provides a baseline for future quality improvement in NW Deanery colonoscopy training.

POSTERS

ty of Colonoscopy Training in the est Deanery

N Prasad, P Shields

Figure 1. Year of Training

n<ﬁed.

33%

ST4 8

25 19%

19%

21%

15 10

ST6 6

ST5 4

Average

0% 1

Never No reply used

Figure 5. Trainee PercepDon of Factors aﬀecDng Colonoscopy Training

Figure 2. Number of Colonoscopies per Level of Training

Number of trainees Minimum number Maximum number

ST3

ST4

ST5

ST6

ST7

108

250

131

129

25.6

68.9

On call commiJments Lack of juniors on the ward

9 4

Missed lists due to senior WR

Trainer takes over too early Training lists not altered to needs

Not enough lists on my rota

103.3 105.7

Nurse endoscopists have priority

3 0

Lists cancelled Too many zero days

Figure 3. Average Number of Colonoscopies per Hospital

Hospital

Number of Trainees

1 2 3 4 5 6 7 8 9 10 11 12 13

13 13 1 6 2 5 7 6 9 13 3 7 3

Total Adjusted Average per year (%) 160 146 125 86 85 83 80 77 67 64 61 45 34

Figure 6. Overall Trainee SaDsfacDon with Colonoscopy Training (1= poor, 5= excellent training) 35 31% 30 25 21%

21%

20 15 10 5 0

Gastroenterology Today - SPRING 2015

ery.

ST7 1

uesDons ing OOP ength of aining to T4 would Dvely.

ved JAG mber of ST7=66 Average ndividual useful or Ts (62%) doscopy. he major ics. 41% and 38% included ed their

ST3 3

OOP 7

must be e and the

Figure 4. Usefulness of Scope Guide (1= unhelpful, 5= invaluable)

No reply

POSTERS

Benefit of real-time cytological examination in EUS gu

Harriet Gordon1,David Lloyd1 Antony Higginson2 Raymond McCrudden3 Cla Eleanor Janynes7 Debra Collins8 David Poller2 Bernard Stacey5 1Gastroenterology, Hampshire Hospitals Foundation Trust, Winchester, 2Ra 3Gastroenterology, Royal Bournemouth County Hospital, 4Radiology, Ro Hospital Southampton, 6Histopathology, Hampshire Hospitals Foundation T 8Histopathology, Royal Bournemouth County Hospital Introduction y Endoscopic ultrasound (EUS) guided sampling of advanced malignant pancreatic lesions is increasingly being performed in order to confirm malignancy prior to chemotherapy and or treatment. y Meta-analysis of 33 studies examining solid lesion EUS FNA tissue acquisition in 4984 patients showed a pooled sensitivity of 85%, increasing to 91% if suspicious atypia was included1.

WINCHESTE

y Higher sensitivities have been demonstrated in large volume single operator centres where sensitivities of 92 - 97%2,3 have been reported. y The four Wessex EUS centres all work from a regional HPB MDT, where pancreatic cases are discussed and EUS procedures requested. Each centre has two EUS operators, performing between 148 and 214 cases per annum. Additionally the regional EUS endoscopists, pathologists and biomedical technicians meet three times a year for EUS network meetings to audit outcomes and review practice standards. Gastroenterology Today - SPRING 2015

y In 3 of the 4 centres cytopathology staff are present in the endoscopy room to provide rapid on site evaluation and confirm adequate sample cellularity and give a preliminary diagnosis.

References 1. Hewitt MJ et al GI endoscopy 2012, 75 (2): 319-331, 2. Cherian et al HPB 2010, 12 (6): 389-395 3. Manzia et al Annals of RC Surgeons England 2010, 92 (4): 295-301

SOUTHAMPTO

PO BOURNEMOUTH

Methods

Each centre prospectively audited the guided biopsy of suspected malignant s lesions over a 6 month period fr 31.12.13. From this data the true po calculated to determine if such netwo results comparable to large volume singl

POSTERS

US guided biopsy of suspected pancreatic malignancy

en3 Clare Bent4 Fanny Shek5 Richard Beable2 Adnan Al-Badri6 Bryan Green7

er, 2Radiology, Queen Alexandra Hospital, Portsmouth, ogy, Royal Bournemouth County Hospital, 5Gastroenterology, University ation Trust, Winchester, 7Histopathology, University Hospital Southampton,

Results Number solid pancreatic masses sampled

INCHESTER

THAMPTON PORTSMOUTH

Sensitivity True negative for malignancy, on clinical / radiological findings

Centre 1

100%

Centre 2

100%

Centre 3

92%

Centre 4

88%

Total

96%

There was a regional sensitivity of 96%. The majority of lesions were adenocarcinoma but other results included: 1 lymphoma, 8 neuroendocrine tumours, 1 renal cell cancer metastasis

Discussion A regional sensitivity of 96% is comparable with results from a single large volume UK EUS centre. This demonstrates that smaller volume centres working within a regional

network can achieve similar standards to high volume centres.

Gastroenterology Today - SPRING 2015

dited the results of EUS alignant solid pancreatic period from 1.7.13 to e true positive rate was ch networking produced ume single centres

Insufficient Number False malignancy negative for sample confirmed malignancy on clinical / radiological findings

POSTERS

The effect of probiotics on

a meta-analysis of random

Eirini Dimidi 1, Stephanos Christodoulides 2, Konstantin

BACKGROU • • • •

Constipation has a prevalence of approximately 14% in adults 1 Several management strategies are currently used, including laxatives, bulking agents and Probiotics are live microorganisms that when administered in adequate amounts confer a h Some probiotics increase short-chain fatty acid production in the large intestine, resulting in

METHOD Aim

The Cochrane and PRISMA recommendati

To investigate the effect of probiotics on gut transit time (GTT), stool output and symptoms in adults with functional constipation

Two reviewers independently performed th extraction, and risk of bias assessment.

Search strategy • four electronic databases (Medline, Embase, Web of Science, CENTRAL) • scanning reference lists • hand searching of abstracts of 8 annual conferences

Statistical analysis

Weighted mean difference (WMD) or st (SMD) were used for relevant outcomes us Statistical heterogeneity was assessed via

RESULT • 14 studies (1,182 participants) were included Whole GTT reduced by 12.4 h (-22.3 to -2.53) Study or Subgroup B. lactis Waller (high) 2011 Waller (low) 2011 Subtotal (95% CI) Test for overall effect: P = 0.18 L. casei Shirota Krammer 2011 Subtotal (95% CI) Test for overall effect: P = 0.07 Total (95% CI) Heterogeneity: Chi² = 2.61, (P = 0.27); I² = 23% Test for overall effect: P = 0.01

Stool frequency increased by + 1.3 bowe

Mean Difference IV, Random, 95% CI

-50 -25 0 25 50 Favours probiotics Favours control

Table 2: Summary of meta-analysis for other symptoms of constipation Gastroenterology Today - SPRING 2015

Standard Mean Difference (95% CI) Stool consistency +0.55 (0.27 to 0.82) Bloating -0.77 (-1.46 to -0.07) Flatulence -0.34 (-0.70 to -0.02) Incomplete evacuation -0.77 (-1.19 to -0.28) Ease of stool expulsion +0.81 (0.15 to 1.48) Outcomes

P value 0.0001 0.03 0.07 0.001 0.02

Study or Subgroup B. lactis Del Piano (C) 2010 Favretto 2013 He 2009 Ishizuka 2012 Takii 2012 Yang 2008 Subtotal (95% CI) HeterogeneityChi² = 61.77 (P < 0.00001); I² = 92% Test for overall effect: P = 0.0001 L. casei Shirota Mazlyn 2013 Tilley 2014 Subtotal (95% CI) Heterogeneity: Chi² = 0.05 (P = 0.83); I² = 0% Test for overall effect: P = 0.50 E. coli Mollenbrink 1994 Subtotal (95% CI) Test for overall effect: P < 0.00001 L. reuteri Ojetti 2013 Subtotal (95% CI) Test for overall effect: P = 0.001 L. plantarum and B. breve Del Piano (B) 2010 Subtotal (95% CI) Test for overall effect: P < 0.00001 Total (95% CI) Heterogeneity: Chi² = 100.81, (P < 0.00001); I² = 90% Test for overall effect: P < 0.0001

CONCLUSION

• Probiotics may be efficacious in the management of functional constipation. They decrease whole gut transit t improve stool consistency and other constipation-related symptoms. • The interpretation of these data is challenging due to the high risk of bias of individual studies and significan RCTs investigating the effect of probiotics on gastrointestinal health in adults with functional constipation are cle 1 King’s College London, Diabetes and Nutritional Sciences Division, London; 2 Ce 3Centre for Gastroenterology and Clinical Nutritio

POSTERS

on functional constipation:

ndomised controlled trials

onstantinos C. Fragkos 3, S. Mark Scott 2, Kevin Whelan 1

CKGROUND

agents and stool softeners, but many patients are dissatisfied with these due to variable efficacy 2 confer a health benefit to the host. There is increasing research regarding the effect of probiotics in constipation resulting in increased propulsive contractions, which may result in reduced gut transit time 3

METHODS

mmendations were followed.

rformed the screening of articles, data sment.

MD) or standardised mean difference tcomes using a random effects model

essed via the I2 statistic

Table 1: Outline of the inclusion criteria PICOS Patients Intervention Comparator Outcomes

Study design

Inclusion Criteria Adults, community/outpatient setting Probiotics alone given in any form Placebo / food or drink without the probiotic Stool frequency Gut transit time Stool consistency Other gastrointestinal symptoms Stool weight Adverse effects / Compliance. RCTs

RESULTS

+ 1.3 bowel actions / week (0.7 to 1.9) Mean Difference IV, Random, 95% CI

); I² = 92%

Selection bias (a) Selection bias (b) Performance bias Detection bias Attrition bias Reporting bias Other bias 0% Low risk of bias

= 0%

25% 50% Unclear risk of bias

75% 100% High risk of bias

Strain-specific analyses

-4 -2 0 2 4 Favors control Favors probiotics

ut transit time, increase stool frequency,

• B. lactis significantly improved rectosigmoid transit time, stool frequency and consistency, and flatulence. It did not improve whole GTT, right and left colonic transit times, stool quantity, sense of incomplete evacuation nor perceived ease of stool expulsion • No effect of L. casei Shirota was detected for stool frequency and consistency, bloating or hard stools

REFERENCES 1. Suares NC, Ford AC (2011) Am J Gastroenterol 106, 1582-91. 2. Johanson JF & Kralstein J (2007) Aliment Pharmacol Ther 25, 599-608.

3. Yajima T (1985) J Physiol 368, 667-78. d significant heterogeneity. Good quality on are clearly needed in the future ndon; 2 Centre for Digestive Diseases, Queen Mary University of London, London cal Nutrition, University College London, London

Gastroenterology Today - SPRING 2015

001); I² = 90%

Assessment of risk of bias

POSTERS

Patient Knowledge of Inflammatory Bow

Richard A. Wardle, Jo University Hospitals Introduction

In the UK, key professional organisations have collaborated to provide inflammatory bowel disease (IBD) Standards to be delivered by the NHS, highlighting the importance of patient education and support.1 Little literature exists however regarding the impact of these standards on patient’s knowledge of their disease.

Purpose

¾ To quantify what patients with Crohn’s disease (CD) and ulcerative colitis (UC) currently understand about their illnesses ¾ To observe the effects of age, sex, ethnicity, diagnosis, disease duration and disease activity ¾ To make a comparison with results collected in 1999

Methods

Gastroenterology Today - SPRING 2015

100 outpatients from Leicester General Hospital and Market Harborough and District Hospital with CD or UC were enrolled to complete the study between May and September 2013. The study questionnaire included patient demographic data and the Crohn’s and Colitis Knowledge Score (CCKNOW).2 The CCKNOW is a 24-item multiple choice questionnaire developed by Dr Jayne Eaden at Leicester General Hospital in 1999. Divided into five clinical areas it assesses general knowledge (8), anatomy (4), medications (5), diet (2) and complications (5). It was originally piloted junior doctors (17), nurses (16), and ward clerks (20) and scores were found to differ significantly between the groups (median scores 22, 16 and 5 respectively, p<0.0001). Patients were excluded from the study if they were under 18, too ill to participate or not willing to complete the questionnaire.

Results

Patient Demographics 58 females, mean age of 49.2 (range 18-75) 42 males, mean age of 47.1 (range 18-77) Mean disease duration was 12.8 (range 0-41) 61 UC, 38 CD

C lo

G d C

Median CCKNOW scores IBD patients 9/24 (95% C.I. 8-11) CD patients 10.5/24, UC 9/24 (p=0.007) CCKNOW Answer Feedback Knowledge Area

Mean % Correct Answers

General Knowledge

48.3

Anatomy

34.8

Medications

Diet

57.5

Complications

Table 1. Knowledge areas assessed by the CCKNOW Mean % correct answers divided by knowledge areas. General knowledge (8), anatomy (4), medications (5), diet (2) and complications (5).

¾ 79% of participants (76% of women) were unaware that women with CD may find it more difficult to become pregnant. ¾ Only 14% of participants (21% of men) were aware that sulphasalazine may cause reduced fertility levels in men which are reversible on stopping medication ¾ Regarding screening of UC patients for cancer of the colon 85% of patients were unaware which patients would be at increased risk.

Gra The rela -0.3

W St nu in re am 19 pe th 9 si st co by cl he

POSTERS

Bowel Disease is no better than in 1999

dle, John F. Mayberry spitals of Leicester

CCKNOW scores achieved were significantly lower with increasing age, p=0.0006 (graph 1). Gender, ethnicity, disease duration or perceived disease activity had no significant effect upon CCKNOW score.

CCKNOW responses (response rate %)

Total CCKNOW score (/24)

Total Score

Linear (Total Score)

r = -0.344412 p = 0.0006

Leicestershire Leicestershire 2013 Eaden et al. 19992 354 (55)

100 (89)

UC (%)

200 (56)

61 (61)

Crohns (%)

154 (44)

38 (38)

Median Score (95% C.I.)

10 (9 -10)

9 (8 -11)

Table 2. Comparison with study conducted by Eaden et al.

0 0

Age (years)

Graph 1. Patient Age vs. Total CCKNOW Score There was a decrease in CCKNOW score with patient age. The relationship was statistically significant, correlation coefficient (r) = -0.344412, p=0.0006.

Discussion

With the recent implementation of the IBD Standards, the growing role of IBD specialist nurses and the increase in accessibility to information on the worldwide web, it would be reasonable to expect that general knowledge amongst IBD patients may have improved since 1999.1,3-5 However CCKNOW questionnaire performance in Leicestershire is no better now than when assessed in 1999, median scores being 9 and 10 respectively (table 2).2,6 The most significant knowledge deficits highlighted by this study relating to the subjects of fertility and the complications of IBD were also highlighted in 1999 by Eaden et al. This may reflect the conflicting clinical evidence available in these areas or hesitancy in broaching such sensitive topics.7

Conclusion

Patient understanding of inflammatory bowel disease may be no better now than when assessed in 1999. There are persisting knowledge deficits regarding the subjects of fertility and the complications of IBD. Elderly patients performed significantly worse than younger counterparts. Further research is required if we are to ever fully understand whether there are real clinical benefits for seeking to improve patient knowledge in IBD.

References 1 Quality

Care Service standards for the healthcare of people who have Inflammatory Bowel Disease (IBD) IBD Standards Group. 2009 http://www.ibdstandards.org.uk/ J, Abrams K, Mayberry J. The Crohn's and colitis knowledge score: a test for measuring patient knowledge in inflammatory bowel disease. American Journal of Gastroenterology 1999 94, 3560â&#x20AC;&#x201C;3566 3 Angelucci E, Orlando A, Ardizzone S, Guidi L, Sorrentino D, Fries W et al. Internet use among inflammatory bowel disease patients: an Italian multicenter survey. Eur J Gastroenterol Hepatol. 2009 Sep;21(9):1036-41. 4 Cima RR, Anderson KJ, Larson DW, Dozois EJ, Hassan I, Sandborn WJ et al. Internet use by patients in an inflammatory bowel disease specialty clinic. Inflamm Bowel Dis. 2007 Oct;13(10):1266-70. 5 Powell J. The doctor, the patient and the world-wide web: how the internet is changing healthcare. J R Soc Med February 2003 vol. 96 no. 2 74-76 6 Wardle RA, Mayberry JF. Patient Knowledge in Inflammatory Bowel Disease: The Crohnâ&#x20AC;&#x2122;s and Colitis Knowledge Score (CCKNOW). European Journal of Gastroenterology and Hepatology. 2014 Jan;26(1):1-5. 7 Fertility and pregnancy in inflammatory bowel disease. 2001. World J Gastroenterology .August 7(4):455-459

2 Eaden

Acknowledgements: Presented at the BSG Annual Meeting 2014. All authors approved the final version of this poster. This study has received no financial support. There are no conflicts of interest. Contact Email: Richardwardle@Hotmail.com

Gastroenterology Today - SPRING 2015

Patient Demographics vs. CCKNOW score

POSTERS

Gastroenterology Today - SPRING 2015

POSTERS

Gastroenterology Today - SPRING 2015

POSTERS

ENDOSCOPY TRANSNASAL GASTROSCOPY ARE THE BIOPSIES SUITABLE FOR BARRETT’S SURVEILLANCE? I N T RO D UC T ION

METHODS

Transnasal gastroscopy is a far more acceptable form of gastroscopy

All patients attending for a follow up gastroscopy for Barrett’s surveillance

to the patient, with benefits including reduced gagging, ability to communicate during the procedure, greater flexibility of endoscope

over the past three years were included in the study.

allowing easier visualisation of difficult areas and closer inspection of the larynx. (1)

procedure when the appointment is booked. The patient is free to choose whichever form of gastroscopy they wish. On admission, the nurse will

Patients attending for gastroscopy are sent information on the types of

Due to the smaller working channel, 2.0mm as compared with 2.8mm of a standard oral gastroscope, the biopsy forceps used in transnasal

explain both procedures again and the patient will then choose. The vast majority choose to have transnasal gastroscopy.

gastroscopy are smaller, leading to questions about the suitability of

For those that choose to have oral gastroscopy, a standard oral gastroscope is used rather than a transnasal gastroscope. All endoscopists take quadrantic biopsies of the Barrett’s segment in accordance with the

transnasal gastroscopy for Barrett’s surveillance. As an early adopter of transnasal gastroscopy, Braintree community hospital endoscopy service has performed many thousands of diagnostic transnasal gastroscopies including Barrett’s surveillance. This study compares the dysplasia and malignancy rate of transnasal gastroscopy biopsies and oral gastroscopy biopsies.

BSG guidelines. The study looked back at 3 years of Barrett’s surveillance and compared the rates of dysplasia found in the transnasal series and the oral series. The overall dysplasia rate, including adenocarcinoma, was compared.

R E SU LT S In the three year period there were a total of 1282 patients who underwent Barrett’s surveillance. Of these, 905 (70.6%) chose to have transnasal gastroscopy, the remainder, 377 (29.4%) chose to have oral gastroscopy. Of the transnasal series, 12 (1.3%) had LGD, 5 (0.6%) had HGD, 3(0.3%) had ACA and 9 (1%) were indefinite for dysplasia. Of the oral series, 7 (1.8%) had LGD, 0(0%) had HGD, 2(0.5%) had ACA and 7 (1.8%) were indefinite for dysplasia. The overall dysplasia and malignancy rate in the trans nasal group versus the oral group was 2.2% versus 2.4%. (p=0.4048)

Gastroenterology Today - SPRING 2015

C O N CLUSION

R E F E R E NCE S

Our series at Braintree community hospital shows that there is not a significant difference in the dysplasia and malignance rate found on transnasal biopsies as compared with oral gastroscopy biopsies.

1. Is the Transnasal Access for Esophagogastroduodenoscopy in Routine Use Equal to the Transoral Route? A Prospective, Randomized Trial. Knuth J, Kunze DE, Benz C, Bullian DR, Heiss MM, Lefering R, Saad S, Saers T, Krakamp B. Z Gastroenterol, 2013 Dec; 51(12): 1369-1376. Disclosure of Interest: None declared

01761SR_Endoscopy Poster A1.indd 1

21/05/2014 10:16

ENDOLIVE UK

12 – 13 March 2015 ICC Birmingham, UK

We invite you to join us at the inaugural Endolive UK meeting which will take place at the International Convention Centre (ICC), Birmingham on Thursday 12 and Friday 13 March 2015. This interactive meeting will showcase UK endoscopy at its best and will also include input from invited international experts: Paul Fockens, Doug Rex and Peter Siersema.

Programme highlights for 2015 include: State of the art interactive scientific programme running over the course of two days Live endoscopy procedures (via video link) from key locations within the UK

‘Meet the Experts’ sessions World-class invited speakers Nurse targeted content Reduced registration rates for nurses and trainees

Participating Centres: London

Glasgow

www.endolive-uk.org.uk

Cardiff

Nottingham

endoliveuk@mci-group.com

POSTERS

Gastroenterology Today - SPRING 2015

COMPANY NEWS

If we discuss patient discomfort and pain with any colonoscopist they will assure that very few of their patients feel pain or discomfort. However, the briefest trawl through public forums will give case after case of patients complaining about the pain they have endured during previous colonoscopies. Most concerning, is the number of patients that are refusing to have a repeat colonoscopy due to this. Some even describe their symptoms in graphic detail and these are all standard indications of a colonoscopy. What is not documented are those patients who don’t even contact their GP’s because of the fear of having the colonoscopy due to friends and relatives describing their experiences. This is a typical comment found on public forums “I WILL NOT have another colonoscopy as it is too much pain”(online public forum) is a common feeling expressed by patients of all ages, having colonoscopies in endoscopy units across the UK. Being able to offer painless colonoscopy will make a big difference to colonoscopy patients, as it would also avoid any risks associated with sedation. Now that colonoscopy is used as a screening tool, being able to offer otherwise healthy and asymptomatic patients a painless screening meaning patients who would otherwise be healthy and asymptomatic would be more willing to have the procedure knowing it is painless than the fear of a painful, invasive procedure. Robotic Colonoscopy Studies into robotic colonoscopy have been taking place since 1995, using different types of locomotion systems inspired by caterpillar type movements. This culminated in the

A sterile, disposable probe with a head, steerable tip and flexible body hosts a vision system and channels for the water jet and air. The locomotion movement is achieved by two clampers located in the proximal and distal part of the probe. Each of the clampers attaches and extends in turn to move the probe. “The proximal clamper adheres to the mucosa and the central part of the body is elongated; the distal clamper adheres to the mucosa and the proximal clamper is released; the central part of the body is contracted so that the proximal clamper may adhere to the mucosa and finally the distal clamp is released. This sequence is repeated several times allowing the probe to move in a wormlike fashion. (Perri at al, 2010). The overall dimensions of the active part are a diameter of 17mm and a variable length from 24 to 40cm. The endoscopist can easily and fully control the disposable probe by means of a hand held console., which can be used to steer the head of the robotic colonoscope 180 degrees in every direction, elongate the soft body to move it backwards and forwards following the shape of the intestine. The patented clamping system allows the probe to hold the colonic tissue by means of a combined vacuum-mechanical action. The system does not create neither lesions in the bowel wall, or mucosal lacerations. Evaluation of the System Studies have evaluated diagnostic accuracy and patient acceptance of robotic colonoscopy with groups of volunteers who also underwent standard colonoscopy procedures. Not only was the diagnostic accuracy the same as standard procedures, in this study, the robotic system was also able to visualise two small polyps in two different patients that were not

seen using a standard colonoscopy. With regard patient acceptance, they were asked to rate on pain and discomfort. Robotic colonoscopy was unanimously rated strongly as better than conventional procedures, scoring on average 0.9 compared to 6.8 respectively (Cosentino et al, 2009) on pain experienced. In a study specifically with patients already diagnosed with inflammatory bowel diseases, the pain/ discomfort ratings were also statistically significantly lower for the robotic colonoscopy. Benefits The main reason of the pain felt by patients undergoing colonoscopy procedures is caused by the excessive stretching of bowel and also the air insufflation. This robotic system is an extremely flexible, soft device, which does not stress the mesenteries in the colon because it can adapt its shape to the configuration of each patient’s bowel and result in a “real painless colonoscopy” (Cosentino et al, 2011). Conclusion Pain and discomfort are the main reasons for incomplete colonoscopies and also for patients refusing the procedure in the first place. This robotic colonoscopy locomotive system has been statistically proven to be as diagnostically accurate, if not more so in some cases, than traditional procedures, and also, due to its soft, flexible construction mean a painless colonoscopy is now a real option. References All references cited in: Felice Costentino, Emanuele Tumino, Giovanni Rubis Passoni, Antonella Rigante, Roberta Barbera, Antonella Tauro and Philipp Emanuel Cosentino (2011). Robotic Colonoscopy, Colonoscopy, Prof. Paul Miskovitz (Ed.) ISBN 978-953-307-568-6, InTech, Available from http://www.intechopen.com/books/ colonoscopy/robotic-colonoscopy

Visit: www.painlesscolonoscopy.co.uk or email: sales@pfemedical.co.uk

Gastroenterology Today - SPRING 2015

The World’s First Painless Colonoscope Interested?

World’s First Painless Colonoscopy

development of the world’s first painless colonoscopy system coming to the UK.

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Endoscope Decontamination using alternative chemistries

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Under increasing pressure to save money on your consumables budget, have you considered alternative chemistries? We can offer you significant cost saving alternative compatible chemistries to clean and disinfect your Endoscopes in your AER’s (EWD’s)

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Carry out a risk assessment for the alternative chemistries

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Include the Trust decision makers that will be affected by a change of chemistry

We can assist you with this exercise, using the previous experience of customers that went through the same process

It is important to involve all the stakeholders that will need to be part of any change

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Request Scope compatibility data and insurance against damage to your equipment or endoscopes We will supply you with all the Detergent and Disinfectant compatibility data required and supply product liability insurance for the AER’s and Endoscopes

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Ensure all the chemistries comply to all the current standards required for the reprocessing of flexible endoscopes EN 13727, EN 14561, EN 13624, EN 14562, EN 14476, EN 14348, EN 14563, EN 14347, EN 13704 and EN 15883-4

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Obtain onsite Type Testing procedure for alternative chemistries

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Request the details of reference sites currently using alternative chemistries

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Ask about our full support for alternative chemistries including servicing, parts and validation

Let us help you expel the myths surrounding the Type Testing of alternative chemistries. Please contact me for more information We have current users of our alternative chemistries who will be more than happy to share their experiences

We use an independent qualified servicing and validation company. Audere Medical Services Ltd has a team of AER qualified engineers

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Consider the purchasing option that works best for you You can purchase direct or from the NHS Supply Chain contract

Contact me to start saving money To discuss the options available and receive a comparative quotation, please contact Matthew Peskett on 01323 511038 or support@peskettsolutions.com

Please note: The definition of an alternative chemistry for this guidance. A chemistry that has a very similar chemical makeup to your existing chemistries and is designed for use in an AER and compatible with Endoscopes, but is not supplied by the manufacturer of the AER.