Linked Color Imaging (LCI) for Colorectal Adenoma Detection

V

Valduce Hospital

Status

Completed

Conditions

Colonic Polyp
Colon Adenoma

Treatments

Device: Linked Color Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT03690297
29052018_LCI

Details and patient eligibility

About

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

Full 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).

Enrollment

600 patients

Sex

All

Ages

50 to 72 years old

Volunteers

No 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.

Trial design

600 participants in 2 patient groups

LCI
Experimental group
Description:
Linked Color Imaging
Treatment:
Device: Linked Color Imaging
WL
Active Comparator group
Description:
White Light
Treatment:
Device: Linked Color Imaging

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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