Endoscopy. 2024 May 15. doi: 10.1055/a-2328-2844. Online ahead of print.
ABSTRACT
BACKGROUND AND STUDY AIM: 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 (PENTAX Medical, Tokyo, Japan) in a varied colonoscopy population.
PATIENTS AND METHODS: A multicenter, randomized trial was conducted at 7 hospitals (both university and non-university) in Europe and Canada. Participants referred for diagnostic, non-iFOBT screening, or surveillance colonoscopy were randomized (1:1) to undergo CADe-assisted or conventional colonoscopy (CC) by experienced endoscopists. Participants with insufficient bowel preparation were excluded from the analysis. Primary outcome was adenoma detection rate (ADR). Secondary outcomes included adenomas per colonoscopy (APC) and sessile serrated lesions per colonoscopy (SSLPC).
RESULTS: In total, 581 participants were enrolled, of which 497 were included in the final analysis: 250 in the CADe-arm and 247 in the CC-arm. Surveillance was the indication in 202/497 (40.6%) colonoscopies, 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 CC. SSLPC was increased (0.30 vs. 0.19; p=0.049) in the CADe-arm vs. CC.
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. (Trialsearch.who.int:NL9135).
PMID:38749482 | DOI:10.1055/a-2328-2844
