ENDOCUFF VISION by McMahon Group

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Reprinted from May 2017

Supported by

ENDOCUFF VISION® Offers Potential for Improved Visibility, Stability, and Control During Colonoscopy Medical Writer Ajai Raj Plano, Texas

Introduction Colonoscopy is one of the most commonly used screening approaches for colorectal cancer (CRC), and has been shown to be effective in reducing CRC mortality.1-3 As with any medical intervention, ongoing efforts to optimize quality are vital, in terms of both national quality benchmarks and emerging innovations in endoscopic technologies and techniques. This article discusses the challenges involved in achieving a quality colonoscopy and reviews the utility of the ENDOCUFF®/ENDOCUFF VISION® (Olympus America Inc). This unique device can be attached to the distal end of an endoscope to achieve better manipulation of mucosal folds and improved scope control (Figure 1). This is particularly useful during the withdrawal phase of colonoscopy, thereby potentially enhancing the endoscopist’s ability to detect hidden polyps and lesions.

Challenges to Achieving High Quality In Colonoscopy Several factors can pose challenges to optimizing the quality of a colonoscopy and contribute to suboptimal detection of adenomas. One factor is the bowel preparation regimen used to cleanse the colon for ease of visualization. Administering 4 L of polyethylene glycol (PEG) in a split dose has been found to be an effective approach.4,5 Lower-volume bowel preparations may be recommended for use in patients who have difficulty with the standard

regimen; for instance 2 L PEG or magnesium citrate are among the recommended bowel preparation regimens recognized by the American Society for Gastrointestinal Endoscopy.4,6,7 The adequacy of cleansing achieved by bowel preparation has been found to critically affect the quality and thoroughness of colonoscopy. A greater quality of cleansing is positively correlated with a higher rate of patients undergoing polypectomy.8 A second challenge can arise in the form of mucosal folds, which can potentially harbor visually hidden adenomas or cancer.9 Related to this challenge is the technical need to keep the scope stable and prevent slippage, particularly during scope withdrawal; higher-quality withdrawal technique has been associated with lower adenoma miss rates.10 Other technical challenges include difficult anatomy as well as potential scope looping, which can reduce visualization and cause patient discomfort.11,12

ENDOCUFF VISION® Designed to Increase Adenoma Detection Rates, Augments Technique The ENDOCUFF VISION® is the next-generation iteration of the previous ENDOCUFF® device, which has been found to significantly improve adenoma detection rates (ADR) (35.4% [95% CI, 29%-41%] vs 20.7% [95% CI, 15%-26%]; P<0.0001), including detection rates of polyps smaller than 1 cm and difficult flat or sessile polyps (N=272 vs 172; P<0.0001 and N=250 vs 145; P<0.0001, respectively).13 The ENDOCUFF VISION® attaches to the distal end of the endoscope and enables the gastroenterologist to manipulate colonic folds, thereby maintaining and maximizing visibility of the mucosa during colonoscopy.14 A row of hinged arms extends from the ENDOCUFF VISION® flattening colonic folds, which in turn improves the depth of field of visualization and prevents slippage during scope withdrawal.14 These arms do not interfere during the intubation phase, as they fold flush against the device until they are needed to be deployed to manipulate mucosal folds.14

ENDOCUFF®-assisted colonoscopy also has shown good success rates in cases of difficult anatomy, including showing good—and in one trial improved—rates and times for cecal intubation.14,15 As noted previously, looping and coiling of the scope during intubation is a common challenge encountered in colonoscopy and can be associated with patient discomfort or pain. The potential to reduce looping may improve the efficiency of colonoscopy and reduces the risk for discomfort and the possibility of injury.11 The ability of the ENDOCUFF VISION® to anchor the tip using the extendable arms was designed to help to prevent and reduce looping. Another advantage of the design of the ENDOCUFF VISION® is that it does not impede, and may even improve, examination of the terminal ileum; while studies have not yet demonstrated an improvement in this area using the ENDOCUFF VISION®, research on similar devices suggests that such an improvement is possible.16 Although the observed improvements in ADR using the ENDOCUFF® device have been explained, including improvements in detection rates for difficult-to-detect small and sessile or flat polyps, they are worth reiterating. One meta-analysis found that the device yielded an enhanced rate of detection of right-sided colonic polyps, of 33.4% compared with 24.0%, based on 3 pooled studies (odds ratio [OR], 1.63; 95% CI, 1.28-2.08; I2=0%; P<0.001).9 Detection of right-sided polyps is of particular note, as it has been reported that

Figure 1. The ENDOCUFF VISION®.

the majority of interval cancers are right-sided.17 These improvements result from the ability of the ENDOCUFF® and ENDOCUFF VISION® to flatten mucosal folds, anchor the tip, and stabilize the scope, particularly during scope withdrawal. This prevents the scope from slipping, increasing control in difficult areas, including around flexures and in the anal verge. The endoscopist need not review the same area of the colon multiple times to account for the scope having slipped. The stabilization provided by the ENDOCUFF® device also has been found to facilitate polypectomy.14 Moreover, the ENDOCUFF VISION® is designed to last and to work well with standard scopes. An internal dry fit grip ensures that the device will stay mounted snugly on the scope during examination, but not so snugly that it will damage the scope when applied or removed.

Conclusion Achieving a quality colonoscopy depends on many factors. Assuming the proper administration of an effective bowel preparation, the technique that the physician is able to bring to the procedure plays a crucial role in adenoma detection. The ENDOCUFF VISION® has the potential to offer endoscopists an enhanced ability to retract mucosal folds, navigate difficult anatomy—both structurally and in terms of motility—and withdraw the scope in a controlled manner.

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES Physician Experiences Using the ENDOCUFF VISION® Aman Ali, MD Wilkes-Barre, Pennsylvania

Seth A. Gross, MD New York, New York

Mark B. Pochapin, MD New York, New York

he experiences of accomplished gastroenterologists with the ENDOCUFF VISION® confirm the benefits documented in the literature. Aman Ali, MD, Wilkes-Barre, Pennsylvania, remarked that the device “is barely noticeable once you start using it” and said it helps him and his colleagues avoid some of the common pitfalls of colonoscopy and maintain a consistently high level of quality. “In our experience, especially on the left side of the colon, behind ileocecal valve, around the flexures, the scope has a tendency to just spring out. So on withdrawal, there are areas where you will just inadvertently withdraw the scope very quickly—it will just slip out of there,” Dr. Ali said. “And if you have the ENDOCUFF VISION® in that area, it helps stabilize the scope. So you’ll have more control, because the prongs coming out of it will hang onto the bends and in between the folds, to give you more stability.” He added, “Since you have more controlled withdrawal time, you have more chances to see lesions—and if you detect more, you can treat more.” Dr. Ali also said the ENDOCUFF VISION® provides stability and consistency when examining spastic colons and in areas where there is a lot of motility, in areas such as the sigmoid colon (Figure 2). “It’s a ‘different feel’ to a withdrawal, as you’re not experiencing a very quick withdrawal in some segments and a much slower withdrawal in others. With ENDOCUFF VISION® you get very consistent and uniform results.” He likened the ability of the ENDOCUFF VISION® to flatten folds to that of a surgical

retractor. “The way a surgeon will ask an assistant to retract the surrounding organs with the help of a surgical retractor, which will take other things out of the way so the surgeon can see the area of interest—similarly, this technique, with the prongs coming out of the device, retracts the folds for you, so you can see behind the folds,” he said. Dr. Ali added that the ENDOCUFF VISION® can be particularly useful for reaching the terminal ileum, noting that while experienced practitioners may not need the assistance of the device in this task, students and newer endoscopists can benefit from it. “The way the ENDOCUFF VISION® retracts folds, it can similarly hook into the ileocecal valve and help you to get into the terminal ileum,” he said. “In the hands of skilled endoscopists, it may not mean much, but for people who are earlier in their learning curve, or junior faculty, they may have a better chance of getting through the ileocecal valve and into the terminal ileum with this device.” He said the ENDOCUFF VISION® compares favorably to transparent caps that can be mounted on the tip of a scope, which he said are useful for seeing behind folds but may not offer the advantages that come with controlled withdrawal of the scope. Mark Pochapin, MD, New York City, echoed Dr. Ali’s comments, saying the ENDOCUFF VISION® can be helpful in enhancing the navigation of particularly difficult or tortuous colons. In addition, he noted that “the device tends to center and anchor the tip of the scope, in the interval between visualizing the polyp and performing the polypectomy. “One area that can be more challenging to view is the cecum, just behind the ileocecal valve. That area can be difficult to see, and can potentially harbor hidden polyps or cancer. You can use the device to pull back the valve and look behind it, as a way to potentially help increase detection of hidden lesions.”

Dr. Pochapin added, “The other area where I find it helpful is the hepatic flexure. The hepatic flexure tends to be tight, and the ENDOCUFF VISION® can enhance the ability to look behind the inner and outer components of the turn in the hepatic flexure.” Dr. Pochapin said he also sees value for this enhanced technology when examining patients who are undergoing surveillance colonoscopy, who are at higher risk for having polyps or cancer due to family history or conditions such as Lynch syndrome.18 “Patients with Lynch syndrome, for example, are at higher risk for more polyps, or more aggressive polyps, and may especially benefit from technology to reduce the rate of missed polyps.” Seth Gross, MD, New York City, likewise said the ENDOCUFF VISION® helps him increase his ADR by allowing him to see behind mucosal folds. In addition to keeping the scope centered and stable, Dr. Gross said it helps prevent looping. “It also allows for more controlled polypectomy, by providing a clear view between the camera and the polyp itself.”

Figure 2. The ENDOCUFF VISION® in descending colon. The ENDOCUFF VISION® is opening up folds in the “spastic” left colon by splaying them open to reveal more surface area.

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18. National Institutes of Health. https://ghr.nlm.nih.gov/condition/lynchsyndrome. Accessed March 28, 2017.

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14. Lenze F, et al. Endoscopy. 2014;46(7):610-614.

Disclaimer: This article is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Olympus, and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of the article, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature. Copyright ÂŠ 2017 McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

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Drs. Ali and Gross reported that they are consultants for Olympus. Dr. Pochapin reported that he has nothing to disclose.