Linked Color Imaging (LCI) for Colorectal Adenoma Detection

Not Applicable

Completed

• Conditions: Colon Adenoma; Colonic Polyp
• Interventions: Device: Linked Color Imaging

• Registration Number: NCT03690297
• Lead Sponsor: Valduce Hospital

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-10-01
• Study Start: 2018-10-15
• Primary Completion: 2019-06-21
• Study Completion: 2019-09-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LCI	Linked Color Imaging	Linked Color Imaging
WL	Linked Color Imaging	White Light

Primary Outcome Measures

Name	Time	Method
Adenoma Detection Rate	1 year	proportion of participants with at least one adenoma (per-patient analysis)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gastroenterology Unit, Valduce Hospital; 🇮🇹 Como, Italy