CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 280 enrolled
Drug / intervention
High-definition white-light endoscopyother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02951390
NCT02951390N/ACompleted

High Definition White-Light Colonoscopy Versus Chromoendoscopy for Surveillance of Lynch Syndrome. A Prospective, Multicenter and Randomized Study

Hospital Clinic of Barcelona·interventional·Posted Nov 1, 2016·Updated Feb 26, 2018

In Brief

A clinical study evaluating High-definition white-light endoscopy for Lynch Syndrome. Completed, enrolled 280 participants across 1 site.

Detailed Summary

Adenomas in Lynch syndrome have an accelerated progression to colorectal cancer (CRC) which might occur despite a regular follow-up. Despite low evidence, high-definition technology (HD) and indigo-carmine chromoendoscopy (CE) are recommended for surveillance in Lynch syndrome.The investigators will conduct a prospective multicenter randomized non-inferiority study. The principal aim is to compare the adenoma detection rate with WLE vs CE. Our hypothesis is that HD-white-light endoscopy (WLE) is not inferior to CE. Therefore - under expert hands - HD-CE does not add any significant advantage over HD-WLE on adenoma detection rate in patients with Lynch syndrome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLynch Syndrome
CountriesSpain

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 1, 2016
Enrollment StartJul 1, 2016
Primary CompletionDec 1, 2017
Study CompletionDec 31, 2017
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.7 years ago

Interventions

High-definition white-light endoscopyother

The intervention is do not perform chromoendoscopy