Evaluation of ArTificial Intelligence System (Gi-Genius) for adenoMa dEtection in Lynch Syndrome. A Randomized, Parallel, Multicenter, Controlled Trial. TIMELY Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 404
- 试验地点
- 4
- 主要终点
- Mean number of adenomas per colonoscopy
研究概览
简要总结
The purpose of this study is to assess if artificial intelligence aid colonoscopy colonoscopy is superior to conventional colonoscopy for the detection of adenomas during surveillance colonoscopy in patients with Lynch syndrome.
详细描述
To compare the performance of white-light colonoscopy (HD-WLE) versus white-light + CAD (CAD) for detection of adenomas (1:1 ratio). The CAD system will include an artificial intelligence-based medical device (GI Genius, Medtronic) trained to process colonoscopy images and superimpose them, in real time, on the endoscopy display as a green box over suspected lesion. An adequate bowel preparation and minimum withdrawal time of 6 min will be required. Colonoscopies will be performed by experienced endoscopists and with high-definition scopes. Lesions will be collected, and histopathology findings used as the reference standard. The primary outcome of this trial will be the mean number of adenomas per colonoscopy (APC).
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
- Double (Participant, Outcomes Assessor)
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
- •Age ≥18 years with a proven pathogenic germline variant in one of the MMR genes (MLH1, MSH2, MSH6) or Epcam deletion who are under surveillance colonoscopy.
排除标准
- •Previous history of total colectomy,
- •Concomitant inflammatory bowel disease,
- •Inability or refuse to sign the informed consent,
- •Previous colonoscopy < 12 months.
- •Inadequate bowel preparation.
- •Incomplete procedure.
- •PMS2 mutation carriers
结局指标
主要结局
Mean number of adenomas per colonoscopy
时间窗: 18 months
Compare mean number of adenomas in both arms calculated by dividing the total number of adenomas detected by the total number of colonoscopies in each arm
次要结局
- Mean number of polyps per colonoscopy(18 months)
- Withdrawal time(18 months)
- False positives in CAD arm(18 months)
- Polyp detection rate(18 months)
- Adenoma detection rate(18 months)
- Mean number of non-clinically significant removed lesions(18 months)
- Subjective endoscopist measures(18 months)
研究者
María Pellisé
Principal Investigator. Attending physician Gastroenterology department.
Hospital Clinic of Barcelona