inked Color Imaging versus high-definition white light endoscopy for the detection of polyps in patients with Lynch syndrome.An international, multicenter, parallel randomized controlled trial.
- Conditions
- The missing rate of colorectal polyps
- Registration Number
- NL-OMON26181
- Lead Sponsor
- Department of Gastroenterology and Hepatology, C2Academic Medical Centre
- Brief Summary
nvt
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 348
Inclusion Criteria
Diagnosis of Lynch-syndrome, with a germline mutation in one of the MMR genes (MLH1, MSH2, MSH6, PMS2)
- Age >18 years
Exclusion Criteria
-Recent surveillance colonoscopy within 1 year from current exam (e.g. after piecemeal EMR) or patients referred for endoscopic evaluation of known colorectal neoplasia.
-Colonoscopy planned for the evaluation of symptoms like rectal blood loss, recent change in bowel habits, weight loss or anemia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The aim of the present study is to compare polyp detection rates of LCI with high-definition white light endoscopy (HD-WLE) in patients with Lynch syndrome in a parallel, international, multicenter, randomized controlled colonoscopy trial.
- Secondary Outcome Measures
Name Time Method Secondary objectives of this study are comparisons of mean number of detected polyps, adenoma detection rate, mean umber of adenomas, mean number of serrated polyps, mean duration of procedures, and sensitivity, specificity and accuracy of optical diagnosis on a per polyp basis.