Clinical trial NCT03344289: Linked Color Imaging Versus High-definition White Light Endoscopy for the Detection of Polyps in Patients With Lynch Syndrome (LCI-LYNCH)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lynch Syndrome
Colonoscopy
Keywords: Linked-color-imaging
Advanced Imaging Techniques
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: FUJIFILM Europe GmbH
First posted: 2017-11-17
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An international, multicenter, parallel randomized controlled trial.
Primary purpose: PREVENTION

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

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.

Eligibility 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.

Primary outcomes:
measure: polyp detection rates
timeFrame: 2 years
Secondary outcomes:
measure: mean number of detected polyps
timeFrame: 2 years
measure: adenoma detection rate
timeFrame: 2 years
measure: mean number of adenomas
timeFrame: 2 years
measure: mean number of serrated polyps
timeFrame: 2 years
measure: mean duration of procedures
timeFrame: 2 years
measure: sensitivity, specificity, and accuracy of optical diagnosis on a per polyp basis
timeFrame: 2 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre
state: Noord-Holland
Study officials:
References:
citation: Houwen BBSL, Hazewinkel Y, Pellise M, Rivero-Sanchez L, Balaguer F, Bisschops R, Tejpar S, Repici A, Ramsoekh D, Jacobs MAJM, Schreuder RM, Kaminski MF, Rupinska M, Bhandari P, van Oijen MGH, Koens L, Bastiaansen BAJ, Tytgat KM, Fockens P, Vleugels JLA, Dekker E. Linked Colour imaging for the detection of polyps in patients with Lynch syndrome: a multicentre, parallel randomised controlled trial. Gut. 2022 Mar;71(3):553-560. doi: 10.1136/gutjnl-2020-323132. Epub 2021 Mar 18.