NCT03272945

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

September 6, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

September 2, 2017

Last Update Submit

January 6, 2019

Conditions

Colonic Polyp

Outcome Measures

Primary Outcomes (1)

  • Average prevalence of flat lesion /patient detected

    The total number of flat colorectal lesion/patient was defined. The average prevalence of flat lesion /patient detected was calculated.

    procedure

Secondary Outcomes (2)

  • Adenoma detection rate

    procedure

  • Polyp detection rate

    procedure

Other Outcomes (1)

  • The visibility of colorectal flat lesions

    1 day

Study Arms (2)

LCI

EXPERIMENTAL

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).

Procedure: Linked-color imaging

WL

PLACEBO COMPARATOR

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).

Procedure: Linked-color imaging

Interventions

Linked-color imagingPROCEDURE

Linked-color imaging colonoscopy

LCIWL

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Showa Inan General hospital

Komagane, Nagano, 399-4191, Japan

Location

Related Publications (1)

  • 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.

    PMID: 33645911DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Akira Horiuchi, MD

    Showa Inan General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Digestive Disease Center

Study Record Dates

First Submitted

September 2, 2017

First Posted

September 6, 2017

Study Start

September 6, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 8, 2019

Record last verified: 2019-01

Locations

JP(1)