Linked Color Imaging vs. White Light for Colorectal Dysplasia in Ulcerative Colitis

May 12, 2016 updated by: Affiliated Hospital to Academy of Military Medical Sciences

Linked Color Imaging (LCI) Versus White Light for the Detection of Colorectal Dysplasia in Ulcerative Colitis

The purpose of the study is to determine whether a new colonoscopic viewing technique called Linked color imaging(LCI) helps endoscopists detect more dysplasia lesions in ulcerative colitis patients than conventional colonoscopy using white light alone.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients with longstanding IBD have increased risk of colorectal cancer (CRC) compared to the general population. The association between duration of the disease and development of CRC is the rationale for endoscopic surveillance. Colonoscopic surveillance of ulcerative colitis patients has been shown to reduce the risk of colorectal cancer and allow detection at an earlier stage, but even with meticulous examination, some precancerous lesions or cancers are missed. The newly developed LCI system (FUJIFILM Co.) creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of BLI technology. LCI makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize a slight difference in color of the mucosa. This is a study to determine if using Linked color imaging (LCI) of the colon, rather than the usual white light on the colon, will improve the detection of more dysplasia lesions in ulcerative colitis.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Affiliated Hospital to Academy of Military Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:patients with ulcerative colitis who meet surveillance criteria Exclusion Criteria:pregnant patients,unable or unwilling to give informed consent,patients with severe active colitis who would be unsafe to endoscope

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
(With LCI endoscopy and 1 month later with white light endoscopy) The patients will be evaluated by Linked Color Imaging and 1 month later evaluated by White Light endoscopy
Device: Linked Color Imaging
Active Comparator: Control group
(With white light endoscopy and 1 month later with LCI endoscopy) The patients will be evaluated by White Light endoscopy and 1 month later evaluated by Linked Color Imaging
Device: white light imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of Colorectal Dysplasia detected by LCI
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The endoscopic scores with LCI
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Investigators

  • Principal Investigator: Yan Liu, M.D.,Ph.D., Affiliated Hospital to Academy of Military Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (Estimate)

May 13, 2016

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 307-LCI-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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