Endoscopy and Endomicroscopy for Assessment of Mucosal Healing in Inflammatory Bowel Disease (IBD)
NCT ID: NCT01524120
Last Updated: 2020-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2012-04-30
Brief Summary
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The main objective of this study is to determine endoscopic and endomicroscopic features of mucosal healing in patients with IBD.
Detailed Description
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Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Crohn's disease (CD)
Patients with CD and mucosal healing on endoscopy.
Endoscopy (EPK-i, Pentax, Tokyo, Japan)
Patients will undergo white-light endoscopy. Any mucosal lesions will be recorded and findings will be compared to histopathological and clinical results.
Crohn's disease
Patients with CD and mucosal healing on endomicroscopy.
Endomicroscopy (iCLE, Pentax, Tokyo, Japan)
Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results.
Ulcerative colitis (UC)
Patients with UC and mucosal healing on endoscopy.
Endoscopy (EPK-i, Pentax, Tokyo, Japan)
Patients will undergo white-light endoscopy. Any mucosal lesions will be recorded and findings will be compared to histopathological and clinical results.
Ulcerative colitis
Patients with UC and mucosal healing on endomicroscopy.
Endomicroscopy (iCLE, Pentax, Tokyo, Japan)
Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results.
Interventions
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Endoscopy (EPK-i, Pentax, Tokyo, Japan)
Patients will undergo white-light endoscopy. Any mucosal lesions will be recorded and findings will be compared to histopathological and clinical results.
Endomicroscopy (iCLE, Pentax, Tokyo, Japan)
Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results.
Endoscopy (EPK-i, Pentax, Tokyo, Japan)
Patients will undergo white-light endoscopy. Any mucosal lesions will be recorded and findings will be compared to histopathological and clinical results.
Endomicroscopy (iCLE, Pentax, Tokyo, Japan)
Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results.
Eligibility Criteria
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Inclusion Criteria
* Age 18-85 years
* Ability of subjects to understand character and individual consequences of clinical trial
* Subjects undergoing colonoscopy
Exclusion Criteria
* Severe Coagulopathy (Prothrombin time \< 50% of control, Partial thromboplastin time \> 50 s)
* Pregnancy or breast feeding
* Active gastrointestinal bleeding
* Residing in institutions (e.g. prison)
* Known allergy against fluorescein
18 Years
85 Years
ALL
No
Sponsors
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University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Principal Investigators
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Markus F. Neurath, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Erlangen-Nürnberg
Helmut Neumann, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Erlangen-Nürnberg
Locations
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University of Erlangen-Nuremberg
Erlangen, , Germany
Countries
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Other Identifiers
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HN-0009
Identifier Type: -
Identifier Source: org_study_id