Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology (SAVE)

Istituto Clinico Humanitas

Status: Enrolling

Conditions: Colonic Neoplasms

Treatments: Device: Standard, high-definition colonoscopy with the use of CADe assistance; Device: Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ; Device: Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ

Study type: Interventional

Funder types: Other

Identifiers

NCT06041945

3483 - SAVE

Details and patient eligibility

About

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.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,800 participants in 3 patient groups

Standard Arm CADe

Active Comparator group

Description:

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.

Treatment:

Device: Standard, high-definition colonoscopy with the use of CADe assistance

Standard Arm CADe/CADx

Active Comparator group

Description:

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.

Treatment:

Device: Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ

Leave-In-Situ Arm

Experimental group

Description:

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.

Treatment:

Device: Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ