Efficacy of a Computer Aided Detection (CADe) system in a FIT-based organized colorectal cancer screening program: a randomized controlled trial (AIFIT study).

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Abstract

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 programs is lacking. This study assesses whether the use of CADe increases the Adenoma Detection Rate (ADR) in FIT-based CRC screening program.In a multicenter, randomized trial, 50-74 years old FIT-positive subjects undergoing colonoscopy, were randomized (1:1) to receive high-definition white light (HDWL) colonoscopy, with or without a real-time deep-learning CADe (CADEYE Fujifilm Co., Tokyo, Japan) by endoscopists with baseline ADR>25%. Main outcomes were ADR (primary outcome), mean number (SD) of adenomas per colonoscopy (APC) and advanced adenoma detection rate (Advanced-ADR). Subgroup analysis according to baseline endoscopists’ ADR (group 1: <40%, group 2: 41-45%, group 3 >46%) was also performed.Eight hundred subjects (median age: 61.0 years, IQR: 55-67; 409 men) were included: 405 underwent CADe-assisted and 395 HDWL colonoscopy, respectively. ADR and APC were significantly higher in the CADe than in the HDWL arm: ADR: 53.6%; 95%CI: [48.6-58.5%] vs. 45.3%; 95%CI [40.3-50.45] (RR: 1.180; 95%CI: [1.026-1.361]); APC: 1.13 (1.54) vs. 0.90 (1.32), p=0.028. No significant difference in advanced-ADR (18.5%; 95%CI [14.8-22.6%] vs. 15.9%; 95%CI [12.5-19.9%]) was found. An increase in ADR was observed in all endoscopists’ groups regardless of baseline ADR.Incorporating CADe significantly increases ADR and APC in the framework of a FIT-based CRC screening program. The impact of CADe appears to be consistent regardless of the endoscopist baseline ADR.Thieme. All rights reserved.