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Linked-color Imaging for the Detection of Colorectal Flat Lesions

Primary Purpose

Colonic Polyp

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Linked-color imaging
Sponsored by
Showa Inan General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Polyp

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Showa Inan General hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LCI

WL

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adenoma detection rate
Adenoma detection rate was defined as the proportion of patients with at least one adenoma found on colonoscopy.
Polyp detection rate
Polyp detection rate was defined as the proportion of patients with at least one polyp found on colonoscopy.

Full Information

First Posted
September 2, 2017
Last Updated
January 6, 2019
Sponsor
Showa Inan General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03272945
Brief Title
Linked-color Imaging for the Detection of Colorectal Flat Lesions
Official Title
Linked-color Imaging Versus White Light for the Detection of Colorectal Flat Lesions: a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 6, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Showa Inan General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LCI
Arm Type
Experimental
Arm Description
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).
Arm Title
WL
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Linked-color imaging
Intervention Description
Linked-color imaging colonoscopy
Primary Outcome Measure Information:
Title
Average prevalence of flat lesion /patient detected
Description
The total number of flat colorectal lesion/patient was defined. The average prevalence of flat lesion /patient detected was calculated.
Time Frame
procedure
Secondary Outcome Measure Information:
Title
Adenoma detection rate
Description
Adenoma detection rate was defined as the proportion of patients with at least one adenoma found on colonoscopy.
Time Frame
procedure
Title
Polyp detection rate
Description
Polyp detection rate was defined as the proportion of patients with at least one polyp found on colonoscopy.
Time Frame
procedure
Other Pre-specified Outcome Measures:
Title
The visibility of colorectal flat lesions
Description
Six endoscopists interpreted the images of CLI and WL. By using a previously reported visibility scale, we scored the visibility level on a scale of 1 to 4 and compared the two groups.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akira Horiuchi, MD
Organizational Affiliation
Showa Inan General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Showa Inan General hospital
City
Komagane
State/Province
Nagano
ZIP/Postal Code
399-4191
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33645911
Citation
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.
Results Reference
derived

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Linked-color Imaging for the Detection of Colorectal Flat Lesions

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