LCI Lynch
Research type
Research Study
Full title
Linked Color Imaging versus high-definition white light endoscopy for the detection of polyps in patients with Lynch syndrome. An international, multi-centre, parallel randomised controlled trial.
IRAS ID
240950
Contact name
Pradeep Bhandari
Contact email
Sponsor organisation
Academic Medical Centre
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 8 days
Research summary
Rationale: Linked Colour 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 colorectal polyps by improving visibility. 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 Colour 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 mutations 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 where colonoscopy is planned for the evaluation of symptoms like; rectal blood loss, recent change in bowel habits, weight loss or anaemia. 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 Colour Imaging colonoscopy or High-Definition White Light Endoscopy after 1:1 randomization. Colonoscopy is associated a small risk of bleeding (1.5%) or perforation (0.1%), however this risk is not increased by the use of LCI.
Main study parameters/endpoints: Polyp detection rate of Linked Colour Imaging versus High-Definition White Light Endoscopy.REC name
West of Scotland REC 1
REC reference
19/WS/0187
Date of REC Opinion
3 Dec 2019
REC opinion
Favourable Opinion