Clinical trial NCT03690297: Linked Color Imaging (LCI) for Colorectal Adenoma Detection
Official title: Linked Color Imaging (LCI) Versus Standard White-light Colonoscopy for Colorectal Adenoma Detection: a Multicenter, Randomized, Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Adenoma
Colonic Polyp
Keywords: adenoma detection rate
Linked Color Imaging
colonoscopy
Lead sponsor: Valduce Hospital
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 600
Sex: ALL
Minimum age (years): 50
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Adenoma Detection Rate
timeFrame: 1 year
Secondary outcomes:
measure: advanced adenoma detection rate
timeFrame: 1 year
measure: mean number per subject of polyps, adenomas, advanced adenomas and sessile serrated lesions
timeFrame: 1 year
measure: Withdrawal time
timeFrame: 1 year
Other outcomes:
Locations:
city: Como
country: Italy
facility: Gastroenterology Unit, Valduce Hospital
Study officials:
affiliation: Valduce Hospital, Como
name: Franco Radaelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paggi S, Radaelli F, Senore C, Maselli R, Amato A, Andrisani G, Di Matteo F, Cecinato P, Grillo S, Sereni G, Sassatelli R, Manfredi G, Alicante S, Buscarini E, Canova D, Milan L, Pallini P, Iwatate M, Rondonotti E, Repici A, Hassan C. Linked-color imaging versus white-light colonoscopy in an organized colorectal cancer screening program. Gastrointest Endosc. 2020 Sep;92(3):723-730. doi: 10.1016/j.gie.2020.05.044. Epub 2020 Jun 2.