Linked Color Imaging (LCI) for Colorectal Adenoma Detection

Status Completed

Clinical Trial 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03690297
Study type	Interventional
Source	Valduce Hospital
Contact
Status	Completed
Phase	N/A
Start date	October 15, 2018
Completion date	September 1, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03272945` - Linked-color Imaging for the Detection of Colorectal Flat Lesions	N/A
Recruiting	`NCT06062095` - Computer Aided Diagnosis (CADx) for Colorectal Polyps Resect-and-Discard Strategy	N/A
Not yet recruiting	`NCT02688699` - Additive Hemostatic Efficacy of EndoClot After EMR or ESD in the Gastrointestinal Tract	Phase 4
Active, not recruiting	`NCT03962868` - Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial	N/A
Not yet recruiting	`NCT05776381` - The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp	Phase 2
Recruiting	`NCT04157803` - Accuracy of aCETIC Acid to Predict Histopathology of Colonic Polyps	N/A
Completed	`NCT03758872` - CUFF-assisted Colonoscopy vs Standard Colonoscopy
Recruiting	`NCT05870332` - Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy
Recruiting	`NCT04149184` - Computer-aided Detection Device in Standard Colonoscopy	N/A
Active, not recruiting	`NCT03865537` - Cold Snare Endoscopic Mucosal Resection Trial	N/A
Recruiting	`NCT05099432` - The CARMA Technique Study	N/A
Withdrawn	`NCT04778566` - Evaluating the Cologuard Test for Use in Lynch Syndrome
Withdrawn	`NCT01372696` - Endoscopic Characteristics of Colonic Tumours	N/A
Recruiting	`NCT05322993` - Improving Polyp Detection Rate by Artificial Intelligence in Colonoscopy	N/A
Completed	`NCT03121495` - Study on Second Forward View Examination in the Right Colon	N/A
Completed	`NCT03344055` - Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate	N/A
Recruiting	`NCT06063720` - Effective Withdrawal Time and Adenoma Detection Rate
Completed	`NCT06426745` - Split-dose Versus Single-dose Bowel Preparation for Colonoscopy	N/A
Recruiting	`NCT04220905` - Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study
Completed	`NCT04693078` - Detection of Colonic Polyps Via a Large Scale Artificial Intelligence (AI) System	N/A