The Yield of Artificial Intelligence (GI Genius) in Lynch Syndrome - A Randomized Tandem-colonoscopy Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- adenoma incremental detection rate
研究概览
简要总结
We aim to investigate the incremental detection rate of polyps using AI- assisted colonoscopy compared with high-definition white-light endoscopy (HD-WLE).
We will conduct a single-center randomized tandem colonoscopy trial of patients with Lynch syndrome with and without AI. Patients will undergo tandem colonoscopy, the second colonoscopy with either HD-WLE or an AI- assisted device.
详细描述
We will include patients with a known pathogenic variant (PV) / likely PV in one of the MMR genes, who are undergoing endoscopic screening and surveillance in our institute. Patients will undergo a first colonoscopy with HD-WLE, and will be randomized at 1:1 ratio to undergo a second colonoscopy with either HD-WLE or an AI- assisted device. All visualized polyps will be removed and size, histology and numbers of polyps detected on each exam will be recorded. We will evaluate the adenoma detection rate and polyp detection rate in each arm and the number of adenomas / polyps in each arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a known pathogenic variant in one of the mismatch repair genes, who are undergoing endoscopic screening and surveillance in our institute
排除标准
- •patients < 18 years old
- •lack of informed consent
- •concomitant inflammatory bowel disease
- •previous total colectomy
- •inadequate bowel cleansing (Boston Bowel Preparation Scale (BBPS) ≤5 or < 2 in one of the 3 segments)
研究组 & 干预措施
high-definition white-light endoscopy
patients undergoing first and second colonoscopy with high-definition white-light endoscopy
artificial intelligence
patients undergoing first colonoscopy with high-definition white-light endoscopy and second colonoscopy with artificial intelligence
干预措施: artificial intelligence (Diagnostic Test)
结局指标
主要结局
adenoma incremental detection rate
时间窗: From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).]
per lesion analysis, the incremental detection rate will be calculated, defined as the number of lesions detected during the second colonoscopy divided by the total number of lesions detected during first and second colonoscopy combined.
adenoma incremental detection rate
时间窗: At the date of enrollment, from the start of colonoscopy until the end of the colonoscopy, in which number of lesions will be detected.
per lesion analysis, the incremental detection rate will be calculated, defined as the number of lesions detected during the second colonoscopy divided by the total number of lesions detected during first and second colonoscopy combined.
次要结局
- incremental detection rate for advanced neoplasia and any polyp(From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).])
- The increment in adenoma detection rate / polyp detection rate(From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).])
- incremental detection rate for advanced neoplasia and any polyp(At the date of enrollment, from the start of colonoscopy until the end of the colonoscopy.)
- The increment in adenoma detection rate / polyp detection rate(At the date of enrollment, from the start of colonoscopy until the end of the colonoscopy.)