Saving by Artificial Intelligence for Virtual Endoscopy Biopsy Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- Non-inferiority in Adenoma Detection Rate
研究概览
简要总结
This three parallel-arms, randomized, multicenter trial is aimed at investigating the value of AI-assisted optical biopsy for differentiating between neoplastic and non-neoplastic polyps which will lead to the implementation of cost-saving strategies in screening programs. A cost-effectiveness analyses with the use of modern trial emulation analyses of large observational and clinical trial datasets and real-cost data will be conducted. To improve personalized treatment with a novel colonoscopy CADx risk-prediction tool, the investigators will even develop a novel deep learning algorithm for the optical biopsy of the alternative pathway of colorectal cancer carcinogenesis, namely the serrated pathway and develop cost-effectiveness models of AI-assisted optical biopsy in colorectal cancer screening that provides reliable information to identify cancer risk regardless of physicians' skill.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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 >40 years-old patients undergoing colonoscopy for selected indications
排除标准
- •patients with personal history of CRC, or IBD
- •patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.
- •patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale <2 in any colonic segment).
- •patients with previous colonic resection.
- •patients on antithrombotic therapy, precluding polyp resection.
- •patients who were not able or refused to give informed written consent.
研究组 & 干预措施
Standard Arm CADe
Standard, high-definition colonoscopy with the use of CADe assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION ,NEC). All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
干预措施: Standard, high-definition colonoscopy with the use of CADe assistance (Device)
Standard Arm CADe/CADx
Standard, high-definition colonoscopy with the use of CADe/CADx assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION ,NEC). All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
干预措施: Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ (Device)
Leave-In-Situ Arm
Standard, high-definition colonoscopy with the use of CADe/CADx assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION, NEC).
Polyps will be left in situ if diminutive (≤5 mm) in size, located in the rectum or sigma and optically diagnosed by the endoscopist using the system to be hyperplastic with high confidence, otherwise resected and sent to pathology.
干预措施: Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ (Device)
结局指标
主要结局
Non-inferiority in Adenoma Detection Rate
时间窗: 4 years
Non-inferiority in the Adenoma Detection Rate, defined as the proportion of participants with at least one adenoma (per-patient analysis) in the three arms, when adopting a cost-saving leave-in-situ strategy for non-neoplastic rectosigmoid diminutive polyps.
次要结局
- Concordance between post-polypectomy surveillance and when adopting a leave-in-situ strategy(4 years)
- Change in the cost of polypectomy and histology in screening programs(4 years)
- Negative Predictive Value for colorectal neoplasia(4 years)