Clinical Trials Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
Artif Intell Med Imaging. Dec 8, 2023; 4(1): 1-9
Published online Dec 8, 2023. doi: 10.35711/aimi.v4.i1.1
Evaluation of computer aided detection during colonoscopy among Veterans: Randomized clinical trial
Mike T Wei, Yu Chen, Susan Y Quan, Jennifer Y Pan, Robert J Wong, Shai Friedland
Mike T Wei, Department of Gastroenterology and Hepatology, Stanford University Medical Center, Palo Alto, CA 94305, United States
Yu Chen, Susan Y Quan, Jennifer Y Pan, Robert J Wong, Shai Friedland, Department of Gastroenterology and Hepatology, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA 94305, United States
Author contributions: Wei MT, Chen Y, Quan SY, Pan JY, Wong R, and Friedland S contributed to collection of data; Wei MT, Pan JY, and Friedland S contributed to data analysis and interpretation; Wei MT and Friedland S contributed to trial design; Wei MT, Chen Y, Quan SY, Pan JY, Wong R, and Friedland S contributed to drafting and revision of manuscript; Chen Y, Quan SY, and Wong R contributed to data interpretation; Friedland S contributed to conception of study.
Institutional review board statement: The study was approved by the institutional review board at Stanford University and was registered at ClinicalTrials.gov (NCT04555135).
Clinical trial registration statement: This registration policy applies to prospective, randomized, controlled trials only.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors declare that they have no conflict of interest.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Mike T Wei, MD, Doctor, Department of Gastroenterology and Hepatology, Stanford University Medical Center, 300 Pasteur Drive, Palo Alto, CA 94305, United States. mtwei@stanford.edu
Received: July 23, 2023
Peer-review started: July 23, 2023
First decision: August 24, 2023
Revised: October 10, 2023
Accepted: October 30, 2023
Article in press: October 30, 2023
Published online: December 8, 2023
ARTICLE HIGHLIGHTS
Research perspectives

The results of this study suggest that computer aided detection (CADe) may not be the right tool for every endoscopist or center. Further studies are needed to understand the impact of CADe on performance quality among endoscopists as well as determine criteria for endoscopists to consider adoption of CADe in their practices.

Research conclusions

In this randomised controlled trial performed at a center with high adenoma detection rate (ADR), use of CADe was found to have decreased adenomas per colonoscopy (APC) and ADR.

Research results

A total of 244 patients were enrolled (124 with CADe). Use of CADe was found to have decreased number of adenomas (1.79 vs 2.53, P = 0.030) per colonoscopy compared to without CADe. Further, use of CADe was found to have lower ADR (68.5% vs 80.0%, P = 0.041) compared to without use of CADe.

Research methods

Adults aged 45 or older presenting for screening or low-risk surveillance were randomized to colonoscopy performed with or without CADe. Primary outcomes included ADR, APC, and adenomas per extraction.

Research objectives

The study study is a single-center, prospective, randomized clinical trial, evaluating the utility of CADe in colonoscopy among veterans.

Research motivation

In September 2020, we performed a randomized clinical trial with Food and Drug Administration (FDA) guidance to evaluate the utility of a CADe. This study initially involved five sites, but partway through the study, due to the high baseline ADR of endoscopists (> 40%) at the Veterans Affairs Palo Alto Health Care System, the FDA mandated that this site not be included as part of the company’s pivotal FDA study. As a result, the original study was split into two, into a community-based study involving four sites, and a separate study involving a Veterans hospital. We present the results from the Veterans Affairs Palo Alto Health Care System site.

Research background

In an effort to reduce risk for polyp miss rate, multiple quality metrics (such as minimal withdrawal time and ADR have been developed to improve colonoscopy quality. The benefit of CADe has been demonstrated across several studies, including by Repici et al.