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
Abstract
BACKGROUND

There has been significant interest in use of computer aided detection (CADe) devices in colonoscopy to improve polyp detection and reduce miss rate.

AIM

To investigate the use of CADe amongst veterans.

METHODS

Between September 2020 and December 2021, we performed a randomized controlled trial to evaluate the impact of CADe. Patients at Veterans Affairs Palo Alto Health Care System presenting for screening or low-risk surveillance were randomized to colonoscopy performed with or without CADe. Primary outcomes of interest included adenoma detection rate (ADR), adenomas per colonoscopy (APC), and adenomas per extraction. In addition, we measured serrated polyps per colonoscopy, non-adenomatous, non-serrated polyps per colonoscopy, serrated polyp detection rate, and procedural time.

RESULTS

A total of 244 patients were enrolled (124 with CADe), with similar patient characteristics (age, sex, body mass index, indication) between the two groups. 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. There was no significant difference in number of serrated polyps or non-adenomatous non-serrated polyps per colonoscopy between the two groups. Overall, use of CADe was found to have lower ADR (68.5% vs 80.0%, P = 0.041) compared to without use of CADe. Serrated polyp detection rate was lower with CADe (3.2% vs 7.5%) compared to without CADe, but this was not statistically significant (P = 0.137). There was no significant difference in withdrawal and procedure times between the two groups or in detection of adenomas per extraction (71.4% vs 73.1%, P = 0.613). No adverse events were identified.

CONCLUSION

While several randomized controlled trials have demonstrated improved ADR and APC with use of CADe, in this RCT performed at a center with high ADR, use of CADe was found to have decreased APC and ADR. Further studies are needed to understand the true impact of CADe on performance quality among endoscopists as well as determine criteria for endoscopists to consider when choosing to adopt CADe in their practices.

Keywords: Colonoscopy, Colorectal cancer prevention, Artificial intelligence, Computer aided detection, Adenoma detection rate

Core Tip: While several randomized controlled trials have demonstrated improved adenoma detection rate (ADR) and adenomas per colonoscopy (APC) with use of computer aided detection (CADe), in this RCT performed by endoscopists with high ADR, use of CADe was found to be associated with decreased APC and ADR. The results of this study suggest that CADe may not be the right tool for every endoscopist. Further studies are needed to understand the impact of CADe on performance quality among endoscopists as well as determine criteria for endoscopists to consider when choosing to adopt CADe in their practices.