Colon to Rectum

Gastroenterology. 2022;163(3):732–41

Shaukat A, Lichtenstein DR, Somers SC, Chung DC, Perdue DG, Gopal M, Colucci DR, Phillips SA, Marka NA, Church TR, Brugge WR; SKOUT™ Registration Study Team

Computer-aided detection improves adenomas per colonoscopy for screening and surveillance colonoscopy: A randomized trial


Background and aims: Colonoscopy for colorectal cancer screening is endoscopist-dependent, and colonoscopy quality improvement programs aim to improve efficacy. This study evaluated the clinical benefit and safety of using a computer-aided detection (CADe) device in colonoscopy procedures.
Methods: This randomized study prospectively evaluated the use of a CADe device at 5 academic and community centers by US board-certified gastroenterologists (n = 22). Participants aged ≥ 40 scheduled for screening or surveillance (≥ 3 years) colonoscopy were included; exclusion criteria included incomplete procedure, diagnostic indication, inflammatory bowel disease, and familial adenomatous polyposis. Patients were randomized by endoscopist to the standard or CADe colonoscopy arm using computer-generated, random-block method. The 2 primary end points were adenomas per colonoscopy (APC), the total number of adenomas resected divided by the total number of colonoscopies; and true histology rate (THR), the proportion of resections with clinically significant histology divided by the total number of polyp resections. The primary analysis used a modified intention-to-treat (ITT) approach.
Results: Between January and September 2021, 1440 participants were enrolled to be randomized. After exclusion of participants who did not meet the eligibility criteria, 677 in the standard arm and 682 in the CADe arm were included in a modified ITT analysis. APC increased significantly with use of the CADe device (standard vs. CADe: 0.83 vs. 1.05, p = 0.002; total number of adenomas, 562 vs. 719). There was no decrease in THR with use of the CADe device (standard vs. CADe: 71.7% vs. 67.4%, pnon-inferiority < 0.001; total number of non-neoplastic lesions, 284 vs. 375). Adenoma detection rate was 43.9% and 47.8% in the standard and CADe arms, respectively (p = 0.065).

Conclusions: For experienced endoscopists performing screening and surveillance colonoscopies in the United States, the computer-aided detection device statistically improved overall adenoma detection (adenomas per colonoscopy) without a concomitant increase in resection of non-neoplastic lesions (true histology rate).

A. Shaukat, M.D., Professor of Medicine, Division of Gastroenterology and Hepatology, NYU Langone Medical Center, New York, NY, USA,
E-Mail: shaukat@umn.edu

DOI: 10.1053/j.gastro.2022.05.028

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