Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation (CADeNCE)

Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation (CADeNCE)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: Device: Computer Assisted Detection

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 Type: Observational
• Enrollment (Estimated): 200000

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Veterans undergoing colonoscopy for any indication at VA facilities across the United States.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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: GI Genius Intelligent Endoscopy Module (Medtronic)
Conventional Colonoscopy; Colonoscopies performed at a VA facility without CADe artificial intelligence available

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma Detection Rate	Change in the proportion of colonoscopies in which one or more adenomas are detected	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Withdrawal time without interventions	Change in the duration of colonoscope withdrawal when no intervention (e.g., polypectomy, biopsy) is performed	Baseline and 6 months
Withdrawal time, including interventions	Change in the duration of colonoscope withdrawal irrespective of interventions	Baseline and 6 months
Adenomas per colonoscopy	Change in the number of adenomas detected per colonoscopy	Baseline and 6 months
Polyp detection rate	Change in the proportion of colonoscopies where one or more adenomas are detected	Baseline and 6 months
Polyps per colonoscopy	Change in the number of polyps detected per colonoscopy	Baseline and 6 months
Provider satisfaction with computer assisted detection for colonoscopy	Provider ratings of satisfaction with the CADe device	6 months
Adenocarcinoma detection rate	Change in the proportion of colonoscopies where colorectal cancer is detected	Baseline and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: VA Puget Sound Health Care System
• Collaborators: San Francisco Veterans Affairs Medical Center; VA Salt Lake City Health Care System
• Investigators: Study Director: Jason A. Dominitz, MD, MHS, US Department of Veterans Affairs

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Veterans; colonoscopy; artificial intelligence; adenoma; quality assurance
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: VHA_NGHP_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes