Rashmee Patil, Mel A. Ona, Emmanuel Ofori and Madhavi Reddy, Department of Internal Medicine, Mount Sinai West, New York, NY, Department of Gastroenterology and Hepatology, The Brooklyn Hospital Center, The Icahn School of Medicine at Mount Sinai, Brooklyn, NY, USA Clinical Endoscopy November 2016 Volume 49, Issue 6, Pages: 533-538
Endocuff (Arc Medical Design) is a U.S. Food and Drug Administration-approved device that is attached like a cap to the distal tip of the colonoscope; it is used to improve adenoma detection rates during colonoscopy. The aim of this review was to summarize and evaluate the clinical and technical efficacy of Endocuff in improving adenoma detection rate. A comprehensive literature review was performed to identify studies describing this technique. In this review article, we have summarized case series and reports describing Endocuff use and results. The reported indications, results, limitations, and complications are discussed.
Summary of Outcomes in Reported Endocuff Studies
Characteristics of Patients in Reported Endocuff Studies
|Study||Country||No. of patients||Age, yr||Sex, male/female||Type of study|
|Sawatzki et al. (2015) ||Switzerland||104||59a)||57/47||Case series|
|Floer et al. (2014) ||Germany||492||64a)||235/257||Case series|
|Lenze et al. (2014) ||Germany||50||57a)||31/19||Case series|
|Chin et al. (2015) ||California, USA||236||NM||NM||Case series|
|Van Doorn et al. (2015) ||The Netherlands||EC, 530||65a)||EC, 264/266||Case series|
|Standard, 533||Standard, 285/248|
|Marsano et al. (2014) ||Not reported||EC, 165||NM||NM||Case series|
|Biecker et al. (2015) ||Germany||498||67a)||249/249||Case series|
|Study||Country||Indications for colonoscopy, n (%)||Cecal intubation, n (%)||Mean cecal intubation time, min||Mean withdrawal time without intervention, min||Polyp detection rate, n (%)||Adenoma detection rate, n (%)||Right-sided adenoma detection, n (%)||Advanced adenomas, n (%)||Adverse events, n (%)|
|Sawatzki et al. (2015) ||Switzerland||Screening, 88/104 (84.6)||103/104 (99)||6||11||75/104 (72)||49/104 (47)||20/49 (41)||14/104(13.5)||Bleeding (after polypectomy), 2/104 (1.9)|
|Polyp follow-up, 16/104 (15.4)||Abdominal pain, 2/104(1.9)|
|Anal fissure, 1/104 (0.96)|
|Floer et al. (2014) ||Germany||Screening, surveillance, diagnostic (anemia or abdominal pain)||EC, 238/249 (96)||NA||EC, 6.32||EC, 138/249 (55.4)||EC, 87/249 (35.4)||EC, 44%||EC, 6/249 (4)||Minor mucosal lacerations: EC, 18/249 (7.3) Standard, 2/243 (0.8)|
|Standard, 229/243 (94)||Standard, 6.05||Standard, 93/243 (38.4)||Standard, 50/243 (207)||Standard, 24%||Standard, 1/243 (1)|
|Lenze et al. (2014) ||Germany||Screening, surveillance, tumor screening||49/50 (98)||6||6.9||NA||21/50 (41)||15/36 (42)||7/36 (19)||Minor mucosal lacerations, 15/50 (30)|
|Chin et al. (2015) ||California, USA||Screening, 97/236 (41)||NM||NM||NM||EC, 78.5%||EC, 44.1%||NM||For flat polyps: EC, 23.8% Standard, 12.3%;||NM|
|Diagnostic||Standard, 57.3%||Standard, 27.3%||For SSA: EC, 10.8% Standard, 4.2%|
|Van Doorn et al. (2015) ||The Netherlands||Polyp surveillance, FIT+screening, sympomatic and >45 years old||EC, 508/520 (98)||EC, 7||EC, 12||NM||EC, 53.5%||NM||NM||NM|
|Standard, 518/525 (99)||Standard, 8.3||Standard, 13||Standard, 52.7%|
|Marsano et al. (2014) ||Not reported||Screening||NM||NM||NM||EC, 1.31/patient||EC, 46.6%||EC, 32.1%||NM||NM|
|Standard, 0.82/ patient||Standard, 30%||Standard, 18.3%|
|Biecker et al. (2015) ||Germany||Screening, surveillance||486/498 (97.6)||NM||NM||EC, 137/245 (56)||EC, 87/240 (36)||NM||24/244 (9.8)||Minor mucosal lacerations: EC, 9/245 (4) Standard, 2/253 (1);|
|Anemia or abdominal pain||Standard, 106/253 (42)||Standard, 69/249 (28)||Loss of cuff: EC, 6/245 (2.5)|
Summary of Outcomes in Reported Endocuff Studies
Colonoscopy performed as a part of colon cancer prevention programs remains the gold standard for CRC screening. The ADR seems to be most crucial in preventing interval colon cancer, as a suboptimal ADR is significantly associated with a higher incidence of CRC. An ADR of at least 20% is generally accepted as sufficient for colon cancer prevention programs and should be the standard for colon cancer prevention centers. Recently, many studies have aimed to achieve a better ADR through various accessory devices (cap assistance, third eye retroscope, EC) and advancements in endoscope design (full spectrum endoscopy system, balloon-assisted colonoscopy, confocal laser endomicroscopy). As a simple attachment to the distal tip of the colonoscope, the EC is an effective and inexpensive alternative for increasing the ADR without restricting the field of vision. The benefit of EC is that it is a safe measure that improves PDR and ADR in a screening population with no severe adverse events, even in patients with diverticulosis. Furthermore, the cecal intubation time is not lengthened, and a significant number of small polyps can be detected in the right side of the colon.
Other technical innovations, like cap-assisted colonoscopy (CAC), back-to-back colonoscopy, or narrow band imaging, have also been evaluated for higher polyp and ADRs. CAC shows conflicting results in terms of improving ADR. In a study by Rastogi et al. , ADR improved with CAC; in contrast, a recently published two-center randomized controlled trial conducted by de Wijkerslooth et al. failed to show an improvement in ADR. When compared to EC, more training is likely to be necessary due to the technical nature of CAC and its effect on the view of the examiner. Furthermore, during CAC, fecal material can become trapped in the cap and impair the visual field; repeated cleaning manoeuvres can be time consuming. In our review of pertinent articles, there was no mention regarding the learning curve timing for precise use of EAC. Most endoscopists included in these case series were experienced and had performed a large volume of colonoscopies prior to use of EAC.
Another upcoming device aimed to increase ADR is the NaviAid G-EYE System (SMART Medical Systems Ltd., Ra’anana, Israel), which includes the G-EYE balloon colonoscope and the NaviAid inflation system. The NaviAid G-EYE colonoscope permanently integrates a balloon onto the flexible tip of a standard colonoscope and is inflatable, reusable, and re-processable. The integrated balloon can be inflated by the endoscopist upon colonoscope withdrawal, to carry out balloon-assisted colonoscopy. The mechanical flattening and straightening of the colonic mucosal folds with the inflated balloon allows visualization of hidden anatomical areas; thus, increasing the ADR. In a prospective study by Hasan et al. , the diagnostic yield of balloon-assisted colonoscopy versus that of standard forward-viewing colonoscopy in the detection of simulated polyps in a colon model was compared. Median PDR for all simulated polyps was significantly higher with the G-EYE balloon colonoscope as compared to that with standard forward-viewing colonoscopy. In the first human study using G-EYE, Gralnek carried out a single-center, prospective cohort study that looked at patients referred for CRC screening, polyp surveillance, or diagnostic evaluation. A total of 44 polyps in 25 of 47 subjects were identified by the G-EYE balloon colonoscope, resulting in a 53.2% PDR. The investigators reported that 36/44 (81.8%) polyps were ‘adenomas,’ with 21/47 subjects having at least one adenoma, yielding a 44.7% ADR. Gralnek concluded that G-EYE appeared to be safe and feasible to use, as the primary end point of this study was safety and efficacy of the device. In a multicentre, randomized, controlled trial comparing standard colonoscopy with G-EYE balloon colonoscopy, Shpak et al. reported that when compared with standard colonoscopy, G-EYE balloon colonoscopy detected an additional 17 adenomas, representing 81% more than that in the group undergoing standard colonoscopy. Furthermore, there was only a 7.5% adenoma miss rate reported with balloon colonoscopy.
As shown in our review article, EAC might have some advantages over standard colonoscopy. Our findings suggest that EAC may result in higher overall ADR and PDR and may be more effective in detecting right-sided adenomas and allowing better inspection of proximal colonic folds. Detection of these polyps that are more likely to be visualized hidden, especially on the reverse side of the mucosal folds, promoted higher ADR and PDR in the EAC group in the studies included in our review. Findings also suggested that EC might facilitate easier polypectomy. This could be as a result of higher friction that allows for avoidance of sudden slippage of the colonoscope because the distal row of EC arms can be used to expose the polyp. Therefore, polypectomy procedures seem to be easier due to a more stable colonoscope position and better visualization by EC. Additionally, EC does not impair the direct wide-angle view of the colonoscope. Finally, in the studies included in our review, no major complications were reported for EC and its use in screening colonoscopy
In conclusion, the EC is a new, safe, and promising attachable device for screening colonoscopy. As a result of our literature review, the EC seems to provide benefits over standard colonoscopy in facilitating complete colonoscopy, improving the visualization of the colonic mucosa, detecting hidden polyps, and improving the overall PDR and ADR. The use of EC is safe and feasible. Recently, the EC device has undergone additional development, with longer arms (EC vision) with the potential to improve ADR further. As previously discussed, improving the ADR correlates with a decrease in colon cancer risk. Future follow-up studies are necessary to demonstrate the impact of EAC on colon cancer-related morbidity and mortality before broad use of the EC device in colon cancer prevention programs can be recommended.