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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03690297
Other study ID # 29052018_LCI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2018
Est. completion date September 1, 2019

Study information

Verified date October 2019
Source Valduce Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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).


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date September 1, 2019
Est. primary completion date June 21, 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years to 72 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy Gastroenterology Unit, Valduce Hospital Como

Sponsors (1)

Lead Sponsor Collaborator
Valduce Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adenoma Detection Rate proportion of participants with at least one adenoma (per-patient analysis) 1 year
Secondary advanced adenoma detection rate proportion of participants with at least one advanced adenoma 1 year
Secondary mean number per subject of polyps, adenomas, advanced adenomas and sessile serrated lesions total number of detected lesions in each group divided by the total number of participants 1 year
Secondary Withdrawal time time for mucosal inspection only 1 year
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