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

Primary Purpose

Ulcerative Colitis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Linked Color Imaging
white light imaging
Sponsored by
Affiliated Hospital to Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ulcerative Colitis focused on measuring ulcerative colitis, colonoscopy, Dysplasia, Diagnosis

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
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

Sites / Locations

  • Affiliated Hospital to Academy of Military Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

(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

(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

Outcomes

Primary Outcome Measures

The number of Colorectal Dysplasia detected by LCI

Secondary Outcome Measures

The endoscopic scores with LCI

Full Information

First Posted
May 12, 2016
Last Updated
May 12, 2016
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02772406
Brief Title
Linked Color Imaging vs. White Light for Colorectal Dysplasia in Ulcerative Colitis
Official Title
Linked Color Imaging (LCI) Versus White Light for the Detection of Colorectal Dysplasia in Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
ulcerative colitis, colonoscopy, Dysplasia, Diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
(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
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
(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
Intervention Type
Device
Intervention Name(s)
Linked Color Imaging
Intervention Type
Device
Intervention Name(s)
white light imaging
Primary Outcome Measure Information:
Title
The number of Colorectal Dysplasia detected by LCI
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The endoscopic scores with LCI
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Min, M.D.,Ph.D.
Phone
+86-010-66947473
Email
minmin823@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaotian Sun, M.D.,Ph.D.
Phone
+86-010-66947473
Email
xiaotian-sun@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Liu, M.D.,Ph.D.
Organizational Affiliation
Affiliated Hospital to Academy of Military Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital to Academy of Military Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Min, M.D.,Ph.D.
Phone
+86-010-66947473
Email
minmin823@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
25952309
Citation
Leifeld L, Rogler G, Stallmach A, Schmidt C, Zuber-Jerger I, Hartmann F, Plauth M, Drabik A, Hofstadter F, Dienes HP, Kruis W; Detect Dysplasia Study Group. White-Light or Narrow-Band Imaging Colonoscopy in Surveillance of Ulcerative Colitis: A Prospective Multicenter Study. Clin Gastroenterol Hepatol. 2015 Oct;13(10):1776-1781.e1. doi: 10.1016/j.cgh.2015.04.172. Epub 2015 May 5.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/25952309
Description
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Linked Color Imaging vs. White Light for Colorectal Dysplasia in Ulcerative Colitis

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