The occurrence of interval cancers after colonoscopy raises the possibility of missed lesions. High- performance computer aided diagnosis (CAD) systems have been specially designed for the detection of colorectal lesions (CAD for detection is named CADe). The use of CADe improves adenoma detection in screening colonoscopy. The potential of CADe system in reducing the rate of progression to advanced polyps or interval cancer between two colonoscopies remains still uncertain.
Patients will be enrolled after a pre-colonoscopy consultation and risk-assessment for colorectal cancer. The screening colonoscopy will be performed by an investigator. Patients will be randomized in the endoscopy room after confirmed cecal intubation and quality of bowel preparation. Randomization into two groups: standard colonoscopy vs. colonoscopy with CADe (CAD EYE or GENIUS) (1:1). A follow-up consultation will be scheduled one-month postcolonoscopy for delivery of histological results and then at 3 years in order to organize the next colonoscopy. As part of the study, a new control colonoscopy will be scheduled for patients with high risk of CRC at 3 years. The 3-year control colonoscopy will be performed with the CAD system for all patients. The colonoscopy will be performed by another investigator who does not know the results nor the type of the first colonoscopy (evaluator blinded). In the low-risk group, we will collect follow-up data as part of routine care, including the results of colonoscopies performed outside of the protocol
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
592
Colonoscopy standard (without CADe)
colonoscopy with CADe
CH de la Côte Basque
Bayonne, France
NOT_YET_RECRUITINGCHU Brest la Cavale Blanche
Brest, France
NOT_YET_RECRUITINGClinique Paris Bercy
Charenton-le-Pont, France
NOT_YET_RECRUITINGCHU de Limoges
Limoges, France
NOT_YET_RECRUITINGInstitut Paoli Calmettes
Marseille, France
NOT_YET_RECRUITINGClinique Jules Verne
Nantes, France
NOT_YET_RECRUITINGCHU Nîmes
Nîmes, France
NOT_YET_RECRUITINGAPHP - Hôpital Saint Antoine
Paris, France
NOT_YET_RECRUITINGAphp-Hegp
Paris, France
NOT_YET_RECRUITINGCHU Bordeaux - Hôpital Haut Lévêque
Pessac, France
RECRUITING...and 3 more locations
Advanced adenoma
The proportion of patients presenting at least one advanced adenoma detected after a 3-year follow-up period. An advanced adenoma is defined as an adenoma or sessile serrate adenoma (SSL) larger than 1cm (size confirmed by the CAD system and/or size estimation by snare), and/or with high-grade dysplasia or neoplasia (confirmed by histological analysis).
Time frame: 36 months
Number of adenoma
Average number of adenoma or SSL (confirmed by histological analysis) detected in each patient during screening colonoscopy after a 3-year follow-up period
Time frame: 36 months
Estimation of the sensitivity of CADx
Estimated sensitivity of CADx (CAD for characterization is named CADx) for the diagnosis and evaluation of colonic polyp's malignancy, with histologic analysis in each center as a reference diagnosis.
Time frame: Day0, 36 months
Estimation of the specificity of CADx
Estimated specificity of CADx (CAD for characterization is named CADx) for the diagnosis and evaluation of colonic polyp's malignancy, with histologic analysis in each center as a reference diagnosis.
Time frame: DAY 0, 36 months
Cost of CADe and classical colonoscopy
The cost of CADe and classical colonoscopy will be estimated using a bottom-up micro costing approach
Time frame: Day 0, 36 months
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