We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Linked-color Imaging for the Detection of Colorectal Flat Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03272945
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Colonic Polyp Procedure: Linked-color imaging

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Linked-color Imaging Versus White Light for the Detection of Colorectal Flat Lesions: a Randomized, Controlled Trial
Actual Study Start Date : September 6, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272945


Contacts
Contact: Akira Horiuchi, MD 81265822121 ext 3012 horiuchi.akira@sihp.jp

Locations
Japan
Showa Inan General hospital Recruiting
Komagane, Nagano, Japan, 399-4191
Contact: Akira Horiuchi, M.D.    81265822121 ext 3012    horiuchi.akira@sihp.jp   
Principal Investigator: Akira Horiuchi, M.D.         
Sponsors and Collaborators
Showa Inan General Hospital
Investigators
Principal Investigator: Akira Horiuchi, MD Showa Inan General Hospital
More Information

Responsible Party: Akira Horiuchi, Chief of Digestive Disease Center, Showa Inan General Hospital
ClinicalTrials.gov Identifier: NCT03272945     History of Changes
Other Study ID Numbers: LCI
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical