About this trial
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.
Eligibility criteria
Qualifiers
All >40 years-old patients undergoing colonoscopy for selected indications
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Standard, high-definition colonoscopy with the use of CADe assistance
- Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ
- Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ