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Completed

NCT Number: NCT03690297

Linked Color Imaging (LCI) for Colorectal Adenoma Detection

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

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Key information

Age range

50 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gastroenterology Unit, Valduce Hospital

Como, 22100, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Linked Color Imaging

Device

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

Primary outcomes

  1. Adenoma Detection Rate

    Time frame: 1 year

    proportion of participants with at least one adenoma (per-patient analysis)

Secondary outcomes

  1. advanced adenoma detection rate

    Time frame: 1 year

    proportion of participants with at least one advanced adenoma

  2. mean number per subject of polyps, adenomas, advanced adenomas and sessile serrated lesions

    Time frame: 1 year

    total number of detected lesions in each group divided by the total number of participants

  3. Withdrawal time

    Time frame: 1 year

    time for mucosal inspection only

Sponsors and collaborators

Lead sponsor

Valduce Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 1, 2018
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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