NCT03690297

Linked Color Imaging (LCI) for Colorectal Adenoma Detection

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Valduce Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 72 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Colon Adenoma
• Colonic Polyp

Interventions

Type	Name	Description
DEVICE	Linked Color Imaging	Use of narrow band imaging with LCI for colon inspection during both insertion and withdrawal phase of colonoscopy

Timeline

• Start date: 2018-10-15
• Primary completion: 2019-06-21
• Completion: 2019-09-01
• First posted: 2018-10-01
• Last updated: 2019-10-02

Locations

1 site across 1 country: Italy