Linked Color Imaging (LCI) for Colorectal Adenoma Detection

NCT ID: NCT03690297

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-15
• Study Completion Date: 2019-09-01

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).

Conditions

Colon Adenoma; Colonic Polyp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

LCI

Linked Color Imaging

Group Type: EXPERIMENTAL

Linked Color Imaging

Intervention Type: DEVICE

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

WL

White Light

Group Type: ACTIVE_COMPARATOR

Linked Color Imaging

Intervention Type: DEVICE

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

Interventions

Linked Color Imaging

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valduce Hospital

OTHER

Sponsor Role: lead

Responsible Party

Franco Radaelli

Principal Investigator, Head Endoscopy Unit, Valduce Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Franco Radaelli, MD

Role: PRINCIPAL_INVESTIGATOR

Valduce Hospital, Como

Locations

Gastroenterology Unit, Valduce Hospital

Como, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 32502550 (View on PubMed)

Other Identifiers

29052018_LCI

Identifier Type: -

Identifier Source: org_study_id