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Completed

NCT Number: NCT03272945

Linked-color Imaging for the Detection of Colorectal Flat Lesions

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.

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Key information

Conditions

Colonic Polyp Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Showa Inan General hospital

Komagane, Nagano, 399-4191, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Linked-color imaging

Procedure

Linked-color imaging colonoscopy

Primary outcomes

  1. Average prevalence of flat lesion /patient detected

    Time frame: procedure

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

Secondary outcomes

  1. Adenoma detection rate

    Time frame: procedure

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

  2. Polyp detection rate

    Time frame: procedure

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

Other outcomes

  1. The visibility of colorectal flat lesions

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Showa Inan General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 6, 2017
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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