Linked-color Imaging for the Detection of Colorectal Flat Lesions

Linked-color Imaging Versus White Light for the Detection of Colorectal Flat Lesions: a Randomized, Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Colonic Polyp
• Intervention / Treatment: Procedure: Linked-color imaging

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Nagano
    • Komagane, Nagano, Japan, 399-4191
      • Showa Inan General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Procedure: Linked-color imaging; Linked-color imaging colonoscopy
Placebo Comparator: 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).	Procedure: Linked-color imaging; Linked-color imaging colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate	Adenoma detection rate was defined as the proportion of patients with at least one adenoma found on colonoscopy.	procedure
Polyp detection rate	Polyp detection rate was defined as the proportion of patients with at least one polyp found on colonoscopy.	procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The visibility of colorectal flat lesions	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.	1 day

Collaborators and Investigators

• Sponsor: Showa Inan General Hospital
• Investigators: Principal Investigator: Akira Horiuchi, MD, Showa Inan General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: September 2, 2017
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: January 6, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Colonic Polyps
• Other Study ID Numbers: LCI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No