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.