Clinical trial NCT05888623: Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation
Official title: Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation (CADeNCE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Keywords: colonoscopy
artificial intelligence
adenoma
Veterans
quality assurance
Lead sponsor: VA Puget Sound Health Care System
Sponsor class: FED
Collaborators: name: VA Salt Lake City Health Care System
name: San Francisco Veterans Affairs Medical Center
First posted: 2023-06-05
Enrollment: 334200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans undergoing colonoscopy for any indication at VA facilities across the United States.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adenoma Detection Rate
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Withdrawal time without interventions
timeFrame: Baseline and 6 months
measure: Withdrawal time, including interventions
timeFrame: Baseline and 6 months
measure: Adenomas per colonoscopy
timeFrame: Baseline and 6 months
measure: Polyp detection rate
timeFrame: Baseline and 6 months
measure: Polyps per colonoscopy
timeFrame: Baseline and 6 months
measure: Provider satisfaction with computer assisted detection for colonoscopy
timeFrame: 6 months
measure: Adenocarcinoma detection rate
timeFrame: Baseline and 6 months
Other outcomes:
measure: Bowel preparation quality
timeFrame: Baseline and 6 months
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: US Department of Veterans Affairs
name: Jason A. Dominitz, MD, MHS
role: STUDY_DIRECTOR
References: