Adenoma detection by Endocuff-assisted versus standard colonoscopy in an organized screening program: the "ItaVision" Randomized Controlled Trial.

Objective Endocuff Vision (EV, Arc Medical Design Ltd., Leeds, England) has shown to increase mucosal exposure, and consequently adenoma detection rate (ADR), during colonoscopy. This nationwide multicentre study assessed possible benefits and harms of implementing EV in a Faecal Immunochemical Test (FIT)-based screening program. Design Patients undergoing colonoscopy after a FIT+ test were randomised 1:1 to receive colonoscopy with EV or standard colonoscopy, stratified by gender, age, and screening history. Primary outcome was ADR, Secondary outcomes were ADR stratified by endoscopists' ADR, advanced ADR (AADR), adenoma per colonoscopy (APC), withdrawal time (WT), and adverse events (AE). Results Overall, 1,864 patients were enrolled in 13 centres. After exclusions, 1,813 (males: 53.7%; mean age: 60.1 years) were randomised, 908 in the EV arm and 905 in the control. ADR was significantly higher in the EV arm (47.8% vs 40.8%; RR 1.17, 95%CI 1.06-1.30) with no differences between arms regarding size or morphology. When stratifying for endoscopists' ADR, only low detectors (ADR< 33.3%) showed a statistically significant ADR increase (EV = 41.1%, 95%CI 35.7-46.7 vs control = 26%, 95%CI 21.3-31.4 . AADR (24.8% vs 20.5%, RR 1.21; 95%CI 1.02-1.43) and APC (0.94 vs. 0.77, p=0.001) were higher in the EV arm. WT and AE were similar between arms. Conclusion EV increased ADR in a FIT-based screening program, supporting a complete exploration of colonic mucosa. Its utility was highest among endoscopists with a low ADR. ClinicalTrial.gov NCT03612674.