Artificial Intelligence-assisted Colonoscopy Versus Conventional Colonoscopy for Missed Lesions in the Proximal Colon: A Prospective Multi-center Randomized Study in Asia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 3
- 主要终点
- Proximal adenoma missed rate
研究概览
简要总结
This is a prospective multi-center randomized study is to determine whether the use of artificial intelligence (AI)-assistance could reduce the miss rates of polyps and adenomas in the proximal colon during tandem examination
详细描述
Centers
- Queen Mary Hospital, Hong Kong, China (Co-ordinating Center)
- Tan Tock Seng Hospital, Singapore, Singapore
- Institute of Gastroenterology and Hepatology, Vietnam Union of Science and Technology Association, Hanoi, Vietnam
Study population
Inclusion:
All adult patients, aged 40 or above, undergoing outpatient colonoscopy in the participating centers will be recruited.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All adult patients, aged 40 or above, undergoing outpatient colonoscopy in the participating centers will be recruited
排除标准
- •history of inflammatory bowel disease
- •history of colorectal cancer
- •previous bowel resection (apart from appendectomy)
- •Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes
- •bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe.
研究组 & 干预措施
Artificial intelligence-Assisted colonoscopy
Tandem colonoscopy of proximal colon assisted with artificial intelligence followed by conventional colonoscopy
干预措施: Artificial intelligence-Assisted colonoscopy (Device)
Artificial intelligence-Assisted colonoscopy
Tandem colonoscopy of proximal colon assisted with artificial intelligence followed by conventional colonoscopy
干预措施: Conventional colonoscopy (Procedure)
Conventional colonoscopy
Tandem conventional colonoscopy of proximal colon followed by usual conventional colonoscopy
干预措施: Conventional colonoscopy (Procedure)
结局指标
主要结局
Proximal adenoma missed rate
时间窗: One day
The proportion of patients with missed adenomas detected in the second examination only
次要结局
- Proximal adenoma detection rate(One day)
- Proximal polyp detection(One day)
- Proximal polyp missed rate(One day)