Impact of Artificial Intelligence for Detection of Precancerous Colonic Lesions in a Fecal Immunochemical Blood Test-Based Organized Screening Program in Italy: A Randomized Control Trial

Background: The fecal immunochemical test (FIT) is widely implemented as a first-line tool in organized colorectal cancer (CRC) screening programs, including Italy. Following a positive FIT, colonoscopy is recommended. Computer-aided detection (CADe) systems have the potential to enhance adenoma detection, particularly in FIT-positive populations where identifying advanced adenomas is critical for cancer prevention. This study evaluated the diagnostic performance of CADe-assisted colonoscopy versus standard colonoscopy (SC) in a FIT-based screening cohort. Methods: In this multicenter, randomized controlled trial, patients with a positive FIT result were randomized to undergo either CADe-assisted or standard colonoscopy. The primary endpoint was the advanced adenoma detection rate (AADR). Secondary endpoints included overall adenoma detection rate (ADR), adenomas per colonoscopy (APC), and mean withdrawal time (WT). Results: Of 1077 patients enrolled, 68 were excluded due to inadequate bowel preparation, leaving 1009 patients for analysis (CADe: n = 506; SC: n = 503). AADR was comparable between the groups (21.3% vs. 20.5%, p = 0.794). However, CADe significantly improved ADR (67.6% vs. 59.8%, p = 0.012) and APC (1.82 ± 2.12 vs. 1.34 ± 1.81, p < 0.001). Mean WT was longer in the CADe group (17.10 ± 8.28 min vs. 16.13 ± 8.28 min, p = 0.016). Conclusions: In a FIT-based organized CRC screening setting, CADe did not enhance detection of AADR with a modest increase in withdrawal time. NCT04441580.