Linked Color Imaging vs. White Light for Colorectal Dysplasia in Ulcerative Colitis
Linked Color Imaging (LCI) Versus White Light for the Detection of Colorectal Dysplasia in Ulcerative Colitis
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 12, 2016
CompletedFirst Posted
Study publicly available on registry
May 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMay 13, 2016
May 1, 2016
6 months
May 12, 2016
May 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of Colorectal Dysplasia detected by LCI
6 months
Secondary Outcomes (1)
The endoscopic scores with LCI
6 months
Study Arms (2)
Experimental group
EXPERIMENTAL(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
Control group
ACTIVE COMPARATOR(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
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Affiliated Hospital to Academy of Military Medical Sciences
Beijing, Beijing Municipality, 100853, China
Related Publications (1)
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.
PMID: 25952309RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan Liu, M.D.,Ph.D.
Affiliated Hospital to Academy of Military Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2016
First Posted
May 13, 2016
Study Start
April 1, 2016
Primary Completion
October 1, 2016
Study Completion
December 1, 2016
Last Updated
May 13, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will share