A computer-aided detection system in the everyday setting of diagnostic, screening, and surveillance colonoscopy: an international, randomized trial.

Background:  Computer-aided detection (CADe) has been developed to improve detection during colonoscopy. After initial reports of high efficacy, there has been an increasing recognition of variability in the effectiveness of CADe systems. The aim of this study was to evaluate a CADe system in a varied colonoscopy population.
Methods:  A multicenter, randomized trial was conducted at seven hospitals (both university and non-university) in Europe and Canada. Participants referred for diagnostic, non-immunochemical fecal occult blood test (iFOBT) screening, or surveillance colonoscopy were randomized (1:1) to undergo CADe-assisted or conventional colonoscopy by experienced endoscopists. Participants with insufficient bowel preparation were excluded from the analysis. The primary outcome was adenoma detection rate (ADR). Secondary outcomes included adenomas per colonoscopy (APC) and sessile serrated lesions (SSLs) per colonoscopy.
Results:  581 participants were enrolled, of whom 497 were included in the final analysis: 250 in the CADe arm and 247 in the conventional colonoscopy arm. The indication was surveillance in 202/497 colonoscopies (40.6 %), diagnostic in 199/497 (40.0 %), and non-iFOBT screening in 96/497 (19.3 %). Overall, ADR (38.4 % vs. 37.7 %; P  = 0.43) and APC (0.66 vs. 0.66; P  = 0.97) were similar between CADe and conventional colonoscopy. SSLs per colonoscopy was increased (0.30 vs. 0.19; P  = 0.049) in the CADe arm vs. the conventional colonoscopy arm.
Conclusions:  In this study conducted by experienced endoscopists, CADe did not result in a statistically significant increase in ADR. However, the ADR of our control group substantially surpassed our sample size assumptions, increasing the risk of an underpowered trial.
Competing Interests: T. Rath has received speaker fees from Olympus Medical, PENTAX Medical, Mauna Kea Technologies, Medtronic, Takeda, Galapagos, Falk, Janssen, AbbVie, Repha, Medical Tribune, and Lilly. C. Spada has received consultancy fees from Medtronic and AnX Robotics, and speaker fees from Olympus, PENTAX Medical, and Norgine. N. Forbes is a consultant for Boston Scientific Corp. and PENTAX Medical, and has received speaker fees and research funding from PENTAX Medical. G. Vanbiervliet has received consultancy fees from Boston Scientific Corp. and Ambu A/S, and lecture and conference fees from Fujifilm Medical, Norgine, Tillots, and PENTAX Medical. P.J. Belletrutti has received speaker fees from Pendopharm and consultancy fees from Vantage Endoscopy. P. Siersema has received research support from The E-Nose company, Lucid Diagnostics, Micro Tech, Magentiq Eye Ltd., Norgine, and Endo Tools Therapeutics, and consultancy fees from Magentiq Eye Ltd. M. Maas, E. Soons, S. Kashin, P. Cesaro, A. Eickhoff and D. Salvi declare that they have no conflict of interest.
(The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).)