Colonic Neoplasms
Conditions
Brief 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.
Interventions
DEVICEStandard, high-definition colonoscopy with the use of CADe assistance
All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
DEVICEStandard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ
All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
DEVICEStandard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ
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.
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All \>40 years-old patients undergoing colonoscopy for selected indications
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-inferiority in Adenoma Detection Rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Negative Predictive Value for colorectal neoplasia | 4 years | Negative Predictive Value for colorectal neoplasia when adopting a leave-in-situ strategy for rectosigmoid diminutive polyps based on the use of Artificial Intelligence. |
| Concordance between post-polypectomy surveillance and when adopting a leave-in-situ strategy | 4 years | Concordance between post-polypectomy surveillance based on strategies based on optical diagnosis with Artificial Intelligence and those based on histology, and when adopting a leave-in-situ strategy for colorectal diminutive polyps based on the use of Artificial Intelligence |
| Change in the cost of polypectomy and histology in screening programs | 4 years | Change in the cost of polypectomy and histology in screening programs, when implementing strategies based on Artificial Intelligence-based optical biopsy, without changes in benefit related with detection of colorectal neoplasia |
Countries
Italy
Contacts
Primary ContactCesare Hassan
Outcome results
None listed