Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
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
Istituto Clinico Humanitas
1,800 participants
Sep 21, 2023
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria1
- All \>40 years-old patients undergoing colonoscopy for selected indications
Exclusion Criteria6
- 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.
Interventions
All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06041945