Evaluation of ArTificial Intelligence System (Gi-Genius) for adenoMa dEtection in Lynch Syndrome. A Randomized, Parallel, Multicenter, Controlled Trial. TIMELY Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lynch Syndrome
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 404
- Locations
- 2
- Primary Endpoint
- Mean number of adenomas per colonoscopy
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to assess if artificial intelligence aid colonoscopy colonoscopy is superior to conventional colonoscopy for the detection of adenomas during surveillance colonoscopy in patients with Lynch syndrome.
Detailed Description
To compare the performance of white-light colonoscopy (HD-WLE) versus white-light + CAD (CAD) for detection of adenomas (1:1 ratio). The CAD system will include an artificial intelligence-based medical device (GI Genius, Medtronic) trained to process colonoscopy images and superimpose them, in real time, on the endoscopy display as a green box over suspected lesion. An adequate bowel preparation and minimum withdrawal time of 6 min will be required. Colonoscopies will be performed by experienced endoscopists and with high-definition scopes. Lesions will be collected, and histopathology findings used as the reference standard. The primary outcome of this trial will be the mean number of adenomas per colonoscopy (APC).
Investigators
María Pellisé
Principal Investigator. Attending physician Gastroenterology department.
Hospital Clinic of Barcelona
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years with a proven pathogenic germline variant in one of the MMR genes (MLH1, MSH2, MSH6) or Epcam deletion who are under surveillance colonoscopy.
Exclusion Criteria
- •Previous history of total colectomy,
- •Concomitant inflammatory bowel disease,
- •Inability or refuse to sign the informed consent,
- •Previous colonoscopy \< 12 months.
- •Inadequate bowel preparation.
- •Incomplete procedure.
- •PMS2 mutation carriers
Outcomes
Primary Outcomes
Mean number of adenomas per colonoscopy
Time Frame: 18 months
Compare mean number of adenomas in both arms calculated by dividing the total number of adenomas detected by the total number of colonoscopies in each arm
Secondary Outcomes
- Mean number of polyps per colonoscopy(18 months)
- Withdrawal time(18 months)
- False positives in CAD arm(18 months)
- Polyp detection rate(18 months)
- Adenoma detection rate(18 months)
- Mean number of non-clinically significant removed lesions(18 months)
- Subjective endoscopist measures(18 months)