CADeNCE: Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the effect of artificial intelligence systems used during colonoscopy on the detection of precancerous polyps in the colon.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Colonoscopy is a key diagnostic and therapeutic procedure for the prevention of colorectal cancer incidence and mortality. Central to colonoscopy's effectiveness is the identification and removal of colorectal neoplasia, including adenomatous polyps and sessile serrated lesions. The endoscopist's adenoma detection rate (ADR), classically defined as the proportion of screening colonoscopies in which one or more adenomas are detected, has been demonstrated to be strongly inversely associated with their patients' risk of post-colonoscopy colorectal cancer. Therefore, improving adenoma detection is a major target of quality assurance efforts.
In 2022, the FDA approved the first artificial intelligence (AI) system for computer assisted detection (CADe) of colorectal neoplasia (also known as colorectal polyps). These CADe devices project an image on the endoscopy monitor (i.e., a bounding box) to alert the endoscopist to the presence of a suspected polyp within the colon. Initial studies, including randomized controlled trials, have demonstrated that use of CADe systems result in a significant improvement in adenoma detection, with a reduction in the miss rate of adenomas (i.e., fewer adenomas are found on a second colonoscopy when the first colonoscopy was performed with a CADe system compared to when the first colonoscopy did not use CADe). However, more recent studies have not demonstrated a clear benefit of these devices. Moreover, most of the additional adenomas that are detected are diminutive polyps, the vast majority of which are thought to be of minimal, if any, clinical significance. When multiple adenomas are detected during colonoscopy, current guidelines recommend repeating colonoscopy sooner than would otherwise be recommended. Also, the CADe systems may have unintended consequences, such as creating alert fatigue through false alarms or negatively impacting training of gastroenterology fellows.
As part of ongoing quality assurance efforts, the Veterans Health Administration's (VHA) National Gastroenterology and Hepatology Program (NGHP) purchased over 100 Medtronic GI Genius CADe devices in late 2022. As funds were not available to supply the CADe systems to all VHA medical centers, these devices were allocated to randomly selected medical centers across the United States.
With the introduction of the CADe devices within the VHA, the NGHP will evaluate the quantitative and qualitative impact and outcomes of use of CADe within VHA medical centers. The NGHP has built a colonoscopy quality dashboard that reports adenoma detection rates for facilities and individual endoscopists at VHA medical centers. For select medical centers, additional quality metrics are also available (e.g., colonoscope withdrawal time, adenomas per colonoscopy, polyps per colonoscopy).
Using these data, outcomes will be compared within facilities (i.e., pre- vs. post-CADe) and between facilities (i.e., facilities with CADe vs. facilities without CADe). Endoscopists at medical centers with CADe devices will be surveyed and interviewed about their use of and satisfaction with these devices.
The initial evaluation will compare outcomes at the facility level. Subsequent analyses will compare outcomes at the individual endoscopist level.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Computer Assisted Detection Colonoscopies performed at a VA facility with computer assisted detection (CADe) artificial intelligence available. |
Device: Computer Assisted Detection
Computer-aided polyp detection system that utilizes artificial intelligence (AI) during colonoscopy
Other Names:
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| Conventional Colonoscopy Colonoscopies performed at a VA facility without CADe artificial intelligence available |
Outcome Measures
Primary Outcome Measures
- Adenoma Detection Rate [Baseline and 6 months]
Change in the proportion of colonoscopies in which one or more adenomas are detected
Secondary Outcome Measures
- Withdrawal time without interventions [Baseline and 6 months]
Change in the duration of colonoscope withdrawal when no intervention (e.g., polypectomy, biopsy) is performed
- Withdrawal time, including interventions [Baseline and 6 months]
Change in the duration of colonoscope withdrawal irrespective of interventions
- Adenomas per colonoscopy [Baseline and 6 months]
Change in the number of adenomas detected per colonoscopy
- Polyp detection rate [Baseline and 6 months]
Change in the proportion of colonoscopies where one or more adenomas are detected
- Polyps per colonoscopy [Baseline and 6 months]
Change in the number of polyps detected per colonoscopy
- Provider satisfaction with computer assisted detection for colonoscopy [6 months]
Provider ratings of satisfaction with the CADe device
- Adenocarcinoma detection rate [Baseline and 6 months]
Change in the proportion of colonoscopies where colorectal cancer is detected
Other Outcome Measures
- Bowel preparation quality [Baseline and 6 months]
Change in the adequacy of bowel preparation during colonoscopy using either the Boston Bowel Prep Scale (0-9, where 9 is best) or the Aronchick Scale (Poor to Excellent)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Colonoscopy performed at a Veterans Affairs (VA) medical center
Exclusion Criteria:
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Colonoscopy performed at VA medical centers that acquired computer-assisted detection artificial intelligence devices through non-random assignment
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Colonoscopy performed at a VA medical center where pathology results are not available
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Puget Sound Health Care System | Seattle | Washington | United States | 98108 |
Sponsors and Collaborators
- VA Puget Sound Health Care System
- VA Salt Lake City Health Care System
- San Francisco Veterans Affairs Medical Center
Investigators
- Study Director: Jason A. Dominitz, MD, MHS, US Department of Veterans Affairs
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VHA_NGHP_001