Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation

Colorectal Neoplasms Clinical Trial

— CADeNCE  

Official title:

Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation (CADeNCE)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05888623
• Other study ID #: VHA_NGHP_001
• Status: Enrolling by invitation
• Start date: October 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2023
• Source: VA Puget Sound Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200000
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Colonoscopy performed at a Veterans Affairs (VA) medical center

Exclusion Criteria:

• Colonoscopy performed at VA medical centers that acquired computer-assisted detection artificial intelligence devices through non-random assignment

• Colonoscopy performed at a VA medical center where pathology results are not available

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Device:
• Computer Assisted Detection
Computer-aided polyp detection system that utilizes artificial intelligence (AI) during colonoscopy

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
VA Puget Sound Health Care System	San Francisco Veterans Affairs Medical Center, VA Salt Lake City Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bowel preparation quality	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)	Baseline and 6 months
Primary	Adenoma Detection Rate	Change in the proportion of colonoscopies in which one or more adenomas are detected	Baseline and 6 months
Secondary	Withdrawal time without interventions	Change in the duration of colonoscope withdrawal when no intervention (e.g., polypectomy, biopsy) is performed	Baseline and 6 months
Secondary	Withdrawal time, including interventions	Change in the duration of colonoscope withdrawal irrespective of interventions	Baseline and 6 months
Secondary	Adenomas per colonoscopy	Change in the number of adenomas detected per colonoscopy	Baseline and 6 months
Secondary	Polyp detection rate	Change in the proportion of colonoscopies where one or more adenomas are detected	Baseline and 6 months
Secondary	Polyps per colonoscopy	Change in the number of polyps detected per colonoscopy	Baseline and 6 months
Secondary	Provider satisfaction with computer assisted detection for colonoscopy	Provider ratings of satisfaction with the CADe device	6 months
Secondary	Adenocarcinoma detection rate	Change in the proportion of colonoscopies where colorectal cancer is detected	Baseline and 6 months