Evaluation of Computer-Aided Detection During Colonoscopy in the Community (AI-SEE): A Multicenter Randomized Clinical Trial

INTRODUCTION: There has been increasing interest in artificial intelligence in gastroenterology. To reduce miss rates during colonoscopy, there has been significant exploration in computer-aided detection (CADe) devices. In this study, we evaluate the use of CADe in colonoscopy in community-based, nonacademic practices. METHODS: Between September 28, 2020, and September 24, 2021, a randomized controlled trial (AI-SEE) was performed evaluating the impact of CADe on polyp detection in 4 community-based endoscopy centers in the United States Patients were block-randomized to undergoing colonoscopy with or without CADe (EndoVigilant). Primary outcomes measured were adenomas per colonoscopy and adenomas per extraction (the percentage of polyps removed that are adenomas). Secondary end points included serrated polyps per colonoscopy; nonadenomatous, nonserrated polyps per colonoscopy; adenoma and serrated polyp detection rates; and procedural time. RESULTS: A total of 769 patients were enrolled (387 with CADe), with similar patient demographics between the 2 groups. There was no significant difference in adenomas per colonoscopy in the CADe and non-CADe groups (0.73 vs 0.67, P = 0.496). Although the use of CADe did not improve identification of serrated polyps per colonoscopy (0.08 vs 0.08, P = 0.965), the use of CADe increased identification of nonadenomatous, nonserrated polyps per colonoscopy (0.90 vs 0.51, P < 0.0001), resulting in detection of fewer adenomas per extraction in the CADe group. The adenoma detection rate (35.9 vs 37.2%, P = 0.774) and serrated polyp detection rate (6.5 vs 6.3%, P = 1.000) were similar in the CADe and non-CADe groups. Mean withdrawal time was longer in the CADe group compared with the non-CADe group (11.7 vs 10.7 minutes, P = 0.003). However, when no polyps were identified, there was similar mean withdrawal time (9.1 vs 8.8 minutes, P = 0.288). There were no adverse events. DISCUSSION: The use of CADe did not result in a statistically significant difference in the number of adenomas detected. Additional studies are needed to better understand why some endoscopists derive substantial benefits from CADe and others do not. ClinicalTrials.gov number: NCT04555135.