Colonoscopy, Colorectal Neoplasms, Intestinal Polyps
Conditions
Keywords
colonoscopy, colorectal neoplasms, computer aided diagnosis
Brief summary
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.
Detailed description
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
Interventions
PROCEDUREStandard colonoscopy
Colonoscopy standard (without CADe)
PROCEDUREColonoscopy CADe
colonoscopy with CADe
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years of age with indication for colonoscopy as part of a screening program, after a positive immunological (FIT) test, and/or for personal or family history of colorectal cancer and/or personal history of colonic adenomas, * Written informed consent signed * Patients covered by a health-care insurance.
Exclusion criteria
* Failed complete colonoscopy, defined by the absence of cecal intubation and/or the absence of terminal ileum cauterization * Inadequate bowel preparation (Boston bowel preparation score \< 6, and/or least at one part of colon with score ≤ 1) * An infiltrative tumor was diagnosed during colonoscope insertion time, not accessible to endoscopic resection and likely to require surgical management (a procedure where part of the colon may need to be removed). * Patient under guardianship or protection * Pregnant women * Not fluent in French or illiterate * Personal history of inflammatory bowel disease * Personal history of genetic predisposition of CRC * Personal history of colonic surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Advanced adenoma | 36 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adenoma | 36 months | Average number of adenoma or SSL (confirmed by histological analysis) detected in each patient during screening colonoscopy after a 3-year follow-up period |
| Estimation of the sensitivity of CADx | Day0, 36 months | 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. |
| Estimation of the specificity of CADx | DAY 0, 36 months | 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. |
| Cost of CADe and classical colonoscopy | Day 0, 36 months | The cost of CADe and classical colonoscopy will be estimated using a bottom-up micro costing approach |
Countries
France
Contacts
CONTACTArthur BERGER, MD
Outcome results
None listed