Linked Color Imaging (LCI) for Colorectal Adenoma Detection

Sponsor

Valduce Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03690297

Collaborator

(none)

600

Enrollment

Location

Arms

10.5

Actual Duration (Months)

56.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Colon Adenoma Colonic Polyp	Device: Linked Color Imaging	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 15, 2018

Actual Primary Completion Date :

Jun 21, 2019

Actual Study Completion Date :

Sep 1, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: LCI

Linked Color Imaging

Device: Linked Color Imaging

Use of narrow band imaging with LCI for colon inspection during both insertion and withdrawal phase of colonoscopy

Active Comparator: WL

White Light

Device: Linked Color Imaging

Use of narrow band imaging with LCI for colon inspection during both insertion and withdrawal phase of colonoscopy

Outcome Measures

Primary Outcome Measures

Adenoma Detection Rate [1 year]
proportion of participants with at least one adenoma (per-patient analysis)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 72 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gastroenterology Unit, Valduce Hospital	Como		Italy	22100

Sponsors and Collaborators

Valduce Hospital

Investigators

Principal Investigator: Franco Radaelli, MD, Valduce Hospital, Como

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Franco Radaelli, Principal Investigator, Head Endoscopy Unit, Valduce Hospital, Valduce Hospital

ClinicalTrials.gov Identifier:

NCT03690297

Other Study ID Numbers:

29052018_LCI

First Posted:

Oct 1, 2018

Last Update Posted:

Oct 2, 2019

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Franco Radaelli, Principal Investigator, Head Endoscopy Unit, Valduce Hospital, Valduce Hospital

adenoma detection rate

Linked Color Imaging

colonoscopy

Additional relevant MeSH terms:

Adenoma

Colonic Polyps

Study Results

No Results Posted as of Oct 2, 2019