Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation (CADeNCE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 334,200
- 试验地点
- 1
- 主要终点
- Adenoma Detection Rate
研究概览
简要总结
The goal of this cluster randomized study is to determine if artificial intelligence systems used during colonoscopy can improve the detection of precancerous polyps in the colon. The primary question it aims to answer is whether computer-assisted detection devices improve the proportion of colonoscopies found to have precancerous adenomatous polyps.
Secondary aims will assess if computer-assisted detection devices improve the proportion of colonoscopies found to other types of precancerous polyps known as sessile serrated lesions, or cancer of the colon and rectum. The study will also assess possible negative effects of use of computer-assisted detection (e.g., prolonging the procedure time or false-positive biopsies) and survey device users to learn about their experience with this technology.
The study team will provide computer-assisted detection devices to randomly chosen VA medical centers for use during colonoscopy and compare colonoscopy findings for patients who undergo colonoscopy at facilities that are equipped with these devices to the findings of patients who undergo colonoscopy at VA facilities that do not have these devices.
A survey will be distributed to physicians who perform colonoscopy to assess their experience using computer-assisted detection devices.
详细描述
Background:
Colonoscopy is a key diagnostic and therapeutic procedure for the prevention of colorectal cancer (CRC) 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.
The Veterans Health Administration's (VA) National Gastroenterology and Hepatology Program (NGHP) has embarked on a number of efforts to measure, monitor, and improve colonoscopy quality across the VA enterprise. One of these efforts is the VA Endoscopy Quality Improvement Program (VA-EQuIP) which is a collaboration between the VA Quality Enhancement Research Initiative (QUERI), the Office of Research and Development (ORD) and the NGHP. Investigators in the Measurement Science QUERI have developed processes for assessing the ADR of individual physicians and facilities through extraction of data from the Corporate Data Warehouse (CDW). Through collaboration with the VA Clinical Assessment Reporting and Tracking Program (CART), more detailed colonoscopy report information is available for 29 VA medical centers, with additional VA facilities expected to be added to the list soon. Overall, the VA ADR for colonoscopies of all indications is 47%1, well above the benchmark of 30% for men undergoing screening colonoscopy.
In 2021, the FDA approved the first artificial intelligence (AI) system for computer assisted detection (CADe) of colorectal neoplasia. 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).2-4 However, more recent studies have not demonstrated a clear benefit of these devices.5,6 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.
Objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colonoscopy performed at a Veterans Affairs (VA) medical center
排除标准
- •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
结局指标
主要结局
Adenoma Detection Rate
时间窗: Baseline and 6 months
Change in the proportion of colonoscopies in which one or more adenomas are detected
次要结局
- Adenocarcinoma detection rate(Baseline and 6 months)
- Sessile serrated lesion detection rate(Baseline and 6 months)
- Proportion of pathology without adenoma or adenocarcinoma(Baseline and 6 months)
- Proportion of colonoscopies with pathology obtained(Baseline and 6 months)
- Withdrawal time without interventions(Baseline and 6 months)
- Provider satisfaction with computer assisted detection for colonoscopy(Approximately 6 months after deployment)
研究者
Jason A. Dominitz, MD, MHS
Executive Director, National Gastroenterology and Hepatology Program
VA Puget Sound Health Care System