Linked-color Imaging for the Detection of Colorectal Flat Lesions

NCT ID: NCT03272945

Last Updated: 2019-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-06

Study Completion Date

2018-12-31

Brief Summary

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Linked color imaging (LCI) was recently developed and uses a laser endoscopic system (Fujifilm Co, Tokyo, Japan) that acquires images by simultaneously using narrow-band short-wavelength light and white-light (WL) in an appropriate balance. LCI is a new image-enhancing technology that is intended to enhance slight color differences in the red region of the mucosa. The acquired color information is reallocated to differentiate colors that are similar to the mucosal color, resulting in improved performance in depicting blood vessels, and additional image processing that enhances color separation for red color permits clear visualization of red blood vessels and white pits. This modality may increase the detection rate of colorectal polyps by enhancing the visibility of colonic mucosal vessels. In addition, it has been reported that LCI increases the visibility of colorectal flat lesions and contributes to improvement of the detection rate for these lesions. The primary aim of the current study was to compare the detection rate of colorectal flat lesions of LCI cap-assisted colonoscopy with WL cap-assisted colonoscopy in prospective randomized trial. In addition, we prospectively compared LCI and WL with regard to the visibility of colorectal flat lesions found in this study.

Detailed Description

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Conditions

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Colonic Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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LCI

Once the randomization assignment was announced, the whole colonoscopy from insertion to cecum to withdrawal of endoscope was carried out entirely by using Linked-color imaging (LCI).

Group Type EXPERIMENTAL

Linked-color imaging

Intervention Type PROCEDURE

Linked-color imaging colonoscopy

WL

Once the randomization assignment was announced, the whole colonoscopy from insertion to cecum to withdrawal of endoscope was carried out entirely by using white light (WL).

Group Type PLACEBO_COMPARATOR

Linked-color imaging

Intervention Type PROCEDURE

Linked-color imaging colonoscopy

Interventions

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Linked-color imaging

Linked-color imaging colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* We enrolled consecutive patients who were referred for colonoscopy to our hospital for diagnostic work up of colonic symptoms, surveillance of colorectal polyps, and colorectal cancer screening.

Exclusion Criteria

* familial colorectal cancer syndrome including familial adenomatous polyposis and hereditary non-polyposis colorectal cancer syndrome, personal history of colorectal cancer or inflammatory bowel disease and those who had previous colonic resection.

Patients who were considered to be unsafe for polypectomy, including patients with bleeding tendency and those with severe comorbid illnesses, were excluded. Those in whom \<90% of mucosa was seen due to mixture of semisolid and solid colonic contents were also excluded because of poor bowel preparation.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Showa Inan General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Akira Horiuchi

Chief of Digestive Disease Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Akira Horiuchi, MD

Role: PRINCIPAL_INVESTIGATOR

Showa Inan General Hospital

Locations

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Showa Inan General hospital

Komagane, Nagano, Japan

Site Status

Countries

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Japan

References

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Kudo T, Horiuchi A, Kyodo R, Horiuchi I, Arai N, Kajiyama M, Tanaka N. Linked colour imaging versus white-light colonoscopy for the detection of flat colorectal lesions: A randomized controlled trial. Colorectal Dis. 2021 Jun;23(6):1414-1420. doi: 10.1111/codi.15605. Epub 2021 Mar 16.

Reference Type DERIVED
PMID: 33645911 (View on PubMed)

Other Identifiers

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LCI

Identifier Type: -

Identifier Source: org_study_id

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