Linked-color Imaging for the Detection of Colorectal Flat Lesions

Study Overview
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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.

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

Conditions
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Colonic Polyp

Intervention / Treatment
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* Procedure: Linked-color imaging


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCI<br>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<br>* Linked-color imaging colonoscopy<br>|
| Placebo Comparator: WL<br>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<br>* Linked-color imaging colonoscopy<br>|

What is the study measuring?
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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 |