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Linked Color Imaging (LCI) for Colorectal Adenoma Detection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03690297
Recruitment Status : Completed
First Posted : October 1, 2018
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Franco Radaelli, Valduce Hospital

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


Condition or disease Intervention/treatment Phase
Colon Adenoma Colonic Polyp Device: Linked Color Imaging Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Linked Color Imaging (LCI) Versus Standard White-light Colonoscopy for Colorectal Adenoma Detection: a Multicenter, Randomized, Trial
Actual Study Start Date : October 15, 2018
Actual Primary Completion Date : June 21, 2019
Actual Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LCI
Linked Color Imaging
Device: Linked Color Imaging
Use of narrow band imaging with LCI for colon inspection during both insertion and withdrawal phase of colonoscopy

Active Comparator: WL
White Light
Device: Linked Color Imaging
Use of narrow band imaging with LCI for colon inspection during both insertion and withdrawal phase of colonoscopy




Primary Outcome Measures :
  1. Adenoma Detection Rate [ Time Frame: 1 year ]
    proportion of participants with at least one adenoma (per-patient analysis)


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03690297


Locations
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Italy
Gastroenterology Unit, Valduce Hospital
Como, Italy, 22100
Sponsors and Collaborators
Valduce Hospital
Investigators
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Principal Investigator: Franco Radaelli, MD Valduce Hospital, Como

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Responsible Party: Franco Radaelli, Principal Investigator, Head Endoscopy Unit, Valduce Hospital, Valduce Hospital
ClinicalTrials.gov Identifier: NCT03690297    
Other Study ID Numbers: 29052018_LCI
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Franco Radaelli, Valduce Hospital:
adenoma detection rate
Linked Color Imaging
colonoscopy
Additional relevant MeSH terms:
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Adenoma
Colonic Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical