Linked Color Imaging Versus High-definition White Light Endoscopy for the Detection of Polyps in Patients With Lynch Syndrome (LCI-LYNCH)

July 13, 2020 updated by: Prof. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Linked 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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rationale: Linked Color Imaging is a push-button endoscopic imaging technique developed to enhance the visibility of the vasculature and architecture of the mucosal surface by narrowing the spectrum of absorbed light. Compared to High-Definition White Light Endoscopy, mucosal surface patterns are better visualized and this could potentially increase the detection of polyps by improving the visibility of colorectal polyps. Patients with Lynch syndrome have accelerated carcinogenesis and even the smallest polyps have malignant potential. Increasing polyp detection rates with new imaging techniques is therefore of importance.

Objective: To compare polyp detection rates of Linked Color Imaging with High-Definition White Light Endoscopy during surveillance colonoscopy in Lynch patients Study design: international, multicentre, parallel, randomized controlled trial Inclusion criteria: Patients diagnosed with Lynch syndrome (proven germline mutation in one of the following MMR genes: MLH1, MSH2, MSH6 or PMS2) aged ≥ 18 years old undergoing surveillance colonoscopy Exclusion criteria: Patients who underwent recent surveillance colonoscopy within 1 year from current exam (e.g. after piecemeal EMR) or patients referred for endoscopic evaluation of known colorectal neoplasia. Patients in whom the colonoscopy is 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.

Intervention: Included patients will undergo surveillance colonoscopy with either Linked Color Imaging colonoscopy or High-Definition White Light Endoscopy after 1:1 randomization.

Main study parameters/endpoints: Polyp detection rate of Linked Color Imaging versus High-Definition White Light Endoscopy Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Each colonoscopy is associated with a small, but not negligible risk of bleeding (~1.5%) or perforation (~0.1%). The use of LCI does not increase the risk of endoscopy.

Study Type

Interventional

Enrollment (Actual)

357

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105AZ
        • Academic Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Lynch-syndrome, with a germline mutation in one of the MMR genes (MLH1, MSH2, MSH6, PMS2)
  • Age >18 years
  • Surveillance colonoscopy for Lynch syndrome.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Linked color imaging
When the patient is randomized for LCI, the imaging mode is switched to LCI and colonoscopic inspection will take place during withdrawal of the endoscope
Diagnostic test: Colonoscopy
Participants will be randomized towards colonoscopy withdrawal with either LCI or HD-WLE
ACTIVE_COMPARATOR: High definition white light
When the patient is randomized for HD-WLE, the imaging mode is switched to HD-WLE and colonoscopic inspection will take place during withdrawal of the endoscope.
Diagnostic test: Colonoscopy
Participants will be randomized towards colonoscopy withdrawal with either LCI or HD-WLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
polyp detection rates
Time Frame: 2 years
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.
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
mean number of detected polyps
Time Frame: 2 years
2 years
adenoma detection rate
Time Frame: 2 years
2 years
mean number of adenomas
Time Frame: 2 years
2 years
mean number of serrated polyps
Time Frame: 2 years
2 years
mean duration of procedures
Time Frame: 2 years
2 years
sensitivity, specificity, and accuracy of optical diagnosis on a per polyp basis
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

FUJIFILM Europe GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 21, 2018

Primary Completion (ACTUAL)

May 1, 2020

Study Completion (ACTUAL)

June 9, 2020

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

November 13, 2017

First Posted (ACTUAL)

November 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL59002.018.16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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