Efficacy of a computer-aided detection system in a fecal immunochemical test-based organized colorectal cancer screening program: a randomized controlled trial (AIFIT study)
Emanuele Rondonotti, Dhanai Di Paolo, E. Rosa Rizzotto, C Alvisi, Elisabetta Buscarini, Marco Spadaccini, Giacomo Tamanini, Silvia Paggi, Arnaldo Amato, Giulia Scardino, S. Romeo, Saverio Alicante, Fabio Ancona, Ennio Guido, Vincenza Marzo, Fabio Chicco, Simona Agazzi, Cesare Rosa, Loredana Correale, Alessandro Repici, Cesare Hassan, Franco Radaelli, on behalf of the AIFIT Study Group
Abstract
Abstract Background Computer-aided detection (CADe) increases adenoma detection in primary screening colonoscopy. The potential benefit of CADe in a fecal immunochemical test (FIT)-based colorectal cancer (CRC) screening program is unknown. This study assessed whether use of CADe increases the adenoma detection rate (ADR) in a FIT-based CRC screening program. Methods In a multicenter, randomized trial, FIT-positive individuals aged 50–74 years undergoing colonoscopy, were randomized (1:1) to receive high definition white-light (HDWL) colonoscopy, with or without a real-time deep-learning CADe by endoscopists with baseline ADR > 25 %. The primary outcome was ADR. Secondary outcomes were mean number of adenomas per colonoscopy (APC) and advanced adenoma detection rate (advanced-ADR). Subgroup analysis according to baseline endoscopists’ ADR (≤ 40 %, 41 %–45 %, ≥ 46 %) was also performed. Results 800 individuals (median age 61.0 years [interquartile range 55–67]; 409 men) were included: 405 underwent CADe-assisted colonoscopy and 395 underwent HDWL colonoscopy alone. ADR and APC were significantly higher in the CADe group than in the HDWL arm: ADR 53.6 % (95 %CI 48.6 %–58.5 %) vs. 45.3 % (95 %CI 40.3 %–50.45 %; RR 1.18; 95 %CI 1.03–1.36); APC 1.13 (SD 1.54) vs. 0.90 (SD 1.32; P = 0.03). No significant difference in advanced-ADR was found (18.5 % [95 %CI 14.8 %–22.6 %] vs. 15.9 % [95 %CI 12.5 %–19.9 %], respectively). An increase in ADR was observed in all endoscopist groups regardless of baseline ADR. Conclusions Incorporating CADe significantly increased ADR and APC in the framework of a FIT-based CRC screening program. The impact of CADe appeared to be consistent regardless of endoscopist baseline ADR.