Endoscopy and Endomicroscopy for Assessment of Mucosal Healing in Inflammatory Bowel Disease (IBD)
1 other identifier
observational
N/A
1 country
1
Brief Summary
Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and histologic features including patterns of inflammation, crypt abscesses and granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure. The main objective of this study is to determine endoscopic and endomicroscopic features of mucosal healing in patients with IBD.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2012
CompletedFirst Posted
Study publicly available on registry
February 1, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedDecember 14, 2020
December 1, 2020
January 23, 2012
December 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mucosal healing
We will determine endoscopic (e.g. ulcera, erythema) and endomicroscopic features of mucosal inflammation (e.g. goblet cell depletion, leackage, microvessel density) in IBD in order to define new criteria of mucosal healing and to define factors of disease remission and relapse.
3 years
Secondary Outcomes (2)
Histologic correlation
3 years
Therapeutic effect
3 years
Study Arms (4)
Crohn's disease (CD)
Patients with CD and mucosal healing on endoscopy.
Crohn's disease
Patients with CD and mucosal healing on endomicroscopy.
Ulcerative colitis (UC)
Patients with UC and mucosal healing on endoscopy.
Ulcerative colitis
Patients with UC and mucosal healing on endomicroscopy.
Interventions
Patients will undergo white-light endoscopy. Any mucosal lesions will be recorded and findings will be compared to histopathological and clinical results.
Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results.
Eligibility Criteria
Patients with Crohn´s disease and ulcerative colitis. Only patients with mucosal healing are included.
You may qualify if:
- Written informed consent
- Age 18-85 years
- Ability of subjects to understand character and individual consequences of clinical trial
- Subjects undergoing colonoscopy
You may not qualify if:
- Inability to provide written informed consent
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Erlangen-Nuremberg
Erlangen, 91054, Germany
Biospecimen
Biopsies were taken from every patient for subsequent histological analysis.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Markus F. Neurath, M.D., Ph.D.
University of Erlangen-Nürnberg
- PRINCIPAL INVESTIGATOR
Helmut Neumann, M.D., Ph.D.
University of Erlangen-Nürnberg
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2012
First Posted
February 1, 2012
Study Start
April 1, 2012
Last Updated
December 14, 2020
Record last verified: 2020-12