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

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ClinicalTrials.gov Identifier: NCT02772406
Recruitment Status : Unknown
Verified May 2016 by Affiliated Hospital to Academy of Military Medical Sciences.
Recruitment status was:  Recruiting
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Device: Linked Color Imaging Device: white light imaging Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Linked Color Imaging (LCI) Versus White Light for the Detection of Colorectal Dysplasia in Ulcerative Colitis
Study Start Date : April 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. The number of Colorectal Dysplasia detected by LCI [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The endoscopic scores with LCI [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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
Contacts and Locations
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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): NCT02772406


Contacts
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Contact: Min Min, M.D.,Ph.D. +86-010-66947473 minmin823@sina.com
Contact: Xiaotian Sun, M.D.,Ph.D. +86-010-66947473 xiaotian-sun@hotmail.com

Locations
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China, Beijing
Affiliated Hospital to Academy of Military Medical Sciences Recruiting
Beijing, Beijing, China, 100853
Contact: Min Min, M.D.,Ph.D.    +86-010-66947473    minmin823@sina.com   
Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
Investigators
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Principal Investigator: Yan Liu, M.D.,Ph.D. Affiliated Hospital to Academy of Military Medical Sciences
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT02772406    
Other Study ID Numbers: 307-LCI-003
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Affiliated Hospital to Academy of Military Medical Sciences:
ulcerative colitis
colonoscopy
Dysplasia
Diagnosis
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases