CLE for Differential Diagnosis of IBD
1 other identifier
observational
105
1 country
1
Brief Summary
Differential diagnosis between Ulcerative Colitis (UC) and Crohn's disease (CD) is of pivotal importance for the management of Inflammatory Bowel Disease (IBD) as both entities involve specific therapeutic management strategies. Confocal Laser Endomicroscopy (CLE) allows on demand in vivo characterization of architectural and cellular details during endoscopy. Here, we assessed the efficacy of CLE to differentiate between UC and CD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2009
Longer than P75 for all trials
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
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 9, 2014
CompletedFirst Posted
Study publicly available on registry
September 12, 2014
CompletedSeptember 12, 2014
September 1, 2014
3.5 years
September 9, 2014
September 11, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with IBD
4 years
Study Arms (2)
Ulcerative colitis
Crohn's disease
Interventions
Eligibility Criteria
Consecutive patients with well-established diagnosis of Crohn's disease and ulcerative colitis.
You may qualify if:
- equal or above 18 years of age
- ability to provide written informed consent
- well-established diagnosis of CD or UC
You may not qualify if:
- history of IBD reclassification in the last 3 years
- Boston Bowel Preparation Scale score's \< 2 in at least one of the three broad regions of the colon (i.e. rectum plus left side colon, transverse colon plus left and right flexures, right colon)
- inability to provide written informed consent
- severe uncontrolled coagulopathy
- impaired renal function
- pregnancy or breast feeding
- active gastrointestinal bleeding
- known allergy to fluorescein
- residence in institutions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Erlangen
Erlangen, 91054, Germany
Related Publications (1)
Tontini GE, Mudter J, Vieth M, Atreya R, Gunther C, Zopf Y, Wildner D, Kiesslich R, Vecchi M, Neurath MF, Neumann H. Confocal laser endomicroscopy for the differential diagnosis of ulcerative colitis and Crohn's disease: a pilot study. Endoscopy. 2015 May;47(5):437-43. doi: 10.1055/s-0034-1391226. Epub 2014 Dec 18.
PMID: 25521573DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helmut Neumann, Professor
University Hospital Erlangen
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 9, 2014
First Posted
September 12, 2014
Study Start
October 1, 2009
Primary Completion
April 1, 2013
Study Completion
September 1, 2014
Last Updated
September 12, 2014
Record last verified: 2014-09