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.

Completed

Conditions: Lynch syndrome
polyps
10017987

Registration Number: NL-OMON50151

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 122

Inclusion Criteria

- Diagnosis of Lynch-syndrome, with a germline mutation in one of the MMR genes
(MLH1, MSH2, MSH6, PMS2)
- Surveillance colonoscopy for Lynch syndrome.
- 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.
- Patients with a concurrent diagnosis of (serrated) polyposis syndrome or
inflammatory bowel disease.
- Patients who are unwilling or unable to give informed consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of the study is the polyp detection rate of HD-WLE and LCI.<br /><br>Polyp detection rates are defined as the number of patients with at least 1<br /><br>polyp detected during the inspection divided by the total number of patients<br /><br>included in the study.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The difference in mean number of polyps between HD-WLE and LCI<br /><br>- The difference in adenoma detection rate between HD-WLE and LCI<br /><br>- The difference in mean number of adenomas between HD-WLE and LCI<br /><br>- The difference in mean number of serrated polyps between HD-WLE and LCI<br /><br>- The mean duration of both endoscopic procedures LCI vs. HD-WLE: time for<br /><br>inspection and time for performing endoscopic resection<br /><br>- The sensitivity, specificity and accuracy of optical diagnosis on a per polyp<br /><br>basis</p><br>