Standard versus Endocuff versus cap‐assisted colonoscopy for adenoma detection: A randomised controlled clinical trial

Abstract

Background and aims Adenoma detection rate (ADR) in colon cancer screening is most important for cancer prophylaxis. This work is the first three-armed randomised controlled clinical trial aimed at comparing a head-to-head setting standard colonoscopy (SC) with Endocuff-assisted colonoscopy (EC) and cap-assisted colonoscopy (CAC) for improvement of ADR. Methods Patients from Poland and Germany with independent indication for colonoscopy were randomised into three arms of this trial: EC, CAC and SC. Exclusion criteria were age <18 years, active Crohn’s disease or ulcerative colitis, known stenosis and post-colonic resection status. Results A total of 585 patients (195 SC, 189 EC and 186 CAC) were enrolled in this study. Indications were not different between the groups (colorectal cancer screening 51%, diagnostic colonoscopy in 31% and post polypectomy follow-up in 18%; p=0.94). Withdrawal time was a mean of seven minutes in all groups ( p=0.658), and bowel preparation did not differ between the groups. The time to reach the caecum was significantly reduced when using the cap (a mean of six minutes for CAC vs. seven minutes for SC; p=0.0001). There was no significant difference in the primary outcome of the ADR between the groups (EC 32%, CAC 30%, SC 30%; p=0.815). EC proved to be superior (EC vs. SC) in the sigmoid colon and transverse colon for polyp detection. Conclusion The use of EC increased the total number of polyps seen during colonoscopy. In contrast to recent studies, no significant improvement of the ADR was detected.

Editorial: Cuff‐ and cap‐assisted colonoscopy: More questions than answers

“…They found no statistically significant difference in ADR between the three groups (EAC 32%, CAC 30%, SC 30%; p = 0.815). 4 In concordance to the results of this study, Marsano et al performed a comparable trial in 2019 and revealed similar results as there was no difference in ARD between EAC, CAC, and SC. 5 However, studies have provided data for the superiority when using a cap 6 or an Endocuff 7 and showed an increased ADR compared to SC, while other studies failed to show any superiority of EAC or CAC on ADR.…”

“…They included 585 patients with half of them that underwent screening colonoscopy. They found no statistically significant difference in ADR between the three groups (EAC 32%, CAC 30%, SC 30%; p = 0.815) 4 …”

High-Definition Colonoscopy Compared With Cuff- and Cap-Assisted Colonoscopy: Results From a Multicenter, Prospective, Randomized Controlled Trial

“…Similar results were noted in a prior UK-based study (N ¼ 711 patients) comparing firstgeneration Endocuff and Cap colonoscopy among highbaseline detectors. 11 Floer et al 15 also recently established in a head-to-head RCT (N ¼ 585 patients) that there was no significant difference in ADR between Endocuff, Reveal Cap, and HDWLE; however, baseline ADR for all groups was low (w30%). The Endocuff was found to detect a higher number of polyps in this trial.…”

“…[9][10][11][12][13] There have been very few randomized studies on direct comparison of CP-assisted colonoscopy, CF-assisted colonoscopy, and standard colonoscopy. 14,15 Efficacy of second generation Endocuff Vision over the commonly used Reveal Cap (US Endoscopy, Mentor, OH) has not been established in a large scale randomized controlled trial (RCT). Furthermore, no prior studies have used the second-generation CF device in a head-to-head clinical trial comparing against high-definition white light colonoscopy (HDWLE) and CF.…”

Michael Manns winner of the 2022 UEG Lifetime Achievement Award

“…He also mentioned time and time again that we should go for decisive studies such as randomised clinical trials. As the Editor‐in‐Chief of the Journal I am happy to say that we receive more and more reports on clinical trials 8,9 . With such a successful track record you can ask yourself does he always pick winners?…”