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

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ClinicalTrials.gov Identifier: NCT03344289
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : July 14, 2020
Sponsor:
Collaborator:
FUJIFILM Europe GmbH
Information provided by (Responsible Party):
Prof. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Lynch Syndrome Colonoscopy Diagnostic Test: Colonoscopy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 357 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An international, multicenter, parallel randomized controlled trial.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.
Actual Study Start Date : January 21, 2018
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : June 9, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. mean number of detected polyps [ Time Frame: 2 years ]
  2. adenoma detection rate [ Time Frame: 2 years ]
  3. mean number of adenomas [ Time Frame: 2 years ]
  4. mean number of serrated polyps [ Time Frame: 2 years ]
  5. mean duration of procedures [ Time Frame: 2 years ]
  6. sensitivity, specificity, and accuracy of optical diagnosis on a per polyp basis [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03344289


Locations
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Netherlands
Academic Medical Centre
Amsterdam, Noord-Holland, Netherlands, 1105AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
FUJIFILM Europe GmbH
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03344289    
Other Study ID Numbers: NL59002.018.16
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Linked-color-imaging
Advanced Imaging Techniques
Additional relevant MeSH terms:
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Colorectal Neoplasms, Hereditary Nonpolyposis
Syndrome
Disease
Pathologic Processes
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases