Linked Color Imaging (LCI) for Colorectal Adenoma Detection

Study Overview
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Brief Summary
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Linked color imaging (LCI) is newly developed image-enhancing endoscopy technology that differentiates the red color spectrum more effectively than white light imaging thanks to its optimal pre-process composition of light spectrum and advanced signal processing. This technology, combined in the latest generation Fujifilm's endoscopes (Fujifilm Co, Tokyo, Japan) with new high-performance LED illumination system, enhances the visibility of colonic mucosal vessels and might increase the detection rate of colorectal polyps. Data available regarding colorectal polyp or adenoma detection with LCI are encouraging but are scanty and limited to back-to back studies. This two parallel arms, randomized, multicenter trial is aimed at evaluating whether LCI is superior to WL endoscopy in terms of adenoma detection

Detailed Description
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50-75 years-old subjects participating in the regional screening program undergoing their first colonoscopy following a positive immunochemical fecal occult blood test (FIT) and meeting all eligibility criteria are randomised 1:1 to LCI (LCI group) or WLI (WL) during insertion and withdrawal phase of colonoscopy. A randomisation list for each participating center was produced by the coordinating center via computer-generated treatment code list. Randomisation is stratified by gender, age (50-60, 61-729 years) and screening history (first vs subsequent test) through an online centralised study database.All procedures are performed with a high-definition ELUXEO 700 series videocolonscopes with or without magnification (EC-760R, EC-760ZP, FUJIFILM Co., Tokyo). The primary outcome measure is the ADR, defined as the proportion of participants with at least one adenoma (per-patient analysis).

Official Title
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Linked Color Imaging (LCI) Versus Standard White-light Colonoscopy for Colorectal Adenoma Detection: a Multicenter, Randomized, Trial

Conditions
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Colon Adenoma, Colonic Polyp

Intervention / Treatment
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* Device: Linked Color Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50-75 years-old subjects participating in the regional screening program undergoing their first colonoscopy following a positive immunochemical fecal occult blood test (FIT) Exclusion Criteria: subjects not eligible for invitation in the screening program (colonoscopy already performed in the previous 5 years, personal history of CRC, colonic adenomas or IBD, severe comorbidity, including end-stage cardiovascular, pulmonary, liver or renal disease) patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale > 2 in any colonic segment) patients with previous colonic resection patients on antithrombotic therapy, precluding polyp resection patients who were not able or refused to give informed written consent.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCI<br>Linked Color Imaging | Device: Linked Color Imaging<br>* Use of narrow band imaging with LCI for colon inspection during both insertion and withdrawal phase of colonoscopy<br>|
| Active Comparator: WL<br>White Light | Device: Linked Color Imaging<br>* Use of narrow band imaging with LCI for colon inspection during both insertion and withdrawal phase of colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma Detection Rate | proportion of participants with at least one adenoma (per-patient analysis) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| advanced adenoma detection rate | proportion of participants with at least one advanced adenoma | 1 year | 
| mean number per subject of polyps, adenomas, advanced adenomas and sessile serrated lesions | total number of detected lesions in each group divided by the total number of participants | 1 year | 
| Withdrawal time | time for mucosal inspection only | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenoma detection rate, Linked Color Imaging, colonoscopy