Linked Color Imaging (LCI) for Colorectal Adenoma Detection

Colonic Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690297
• Other study ID #: 29052018_LCI
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: October 2019
• Source: Valduce Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: September 1, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 72 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Colon Adenoma
• Colonic Polyp
• Colonic Polyps

Intervention

Device:
• Linked Color Imaging
Use of narrow band imaging with LCI for colon inspection during both insertion and withdrawal phase of colonoscopy

Locations

Country	Name	City	State
Italy	Gastroenterology Unit, Valduce Hospital	Como

Sponsors (1)

Lead Sponsor	Collaborator
Valduce Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma Detection Rate	proportion of participants with at least one adenoma (per-patient analysis)	1 year
Secondary	advanced adenoma detection rate	proportion of participants with at least one advanced adenoma	1 year
Secondary	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
Secondary	Withdrawal time	time for mucosal inspection only	1 year