Endomicroscopy for Assessment of Mucosal Healing
December 10, 2020 updated by: University of Erlangen-Nürnberg Medical School
Advanced Endoscopic Imaging Using Endomicroscopy for Assessment of Mucosal Healing in IBD
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 endomicroscopic features of mucosal healing in patients with IBD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
84
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Erlangen, Germany, 91054
- University of Erlangen-Nuremberg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Crohn´s disease and ulcerative colitis in the active and quiescent phase of the disease.
Description
Inclusion Criteria:
- Written informed consent
- Age 18-85 years
- Ability of subjects to understand character and individual consequences of clinical trial
- Subjects undergoing colonoscopy
Exclusion Criteria:
- 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
- Proctocolectomy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Crohn´s disease - active
Patients with Crohn´s disease in the active phase.
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Patients will undergo advanced endoscopic imaging using endomicroscopy.
Findings will be compared to histopathological and clinical results.
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Crohn´s disease - quiescent
Patients with Crohn´s disease in the quiescent phase.
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Patients will undergo advanced endoscopic imaging using endomicroscopy.
Findings will be compared to histopathological and clinical results.
|
|
Ulcerative colitis - active
Patients with ulcerative colitis in the active stage.
|
Patients will undergo advanced endoscopic imaging using endomicroscopy.
Findings will be compared to histopathological and clinical results.
|
|
Ucerative colitis - quiescent
Patients with ulcerative colitis in the quiescent stage.
|
Patients will undergo advanced endoscopic imaging using endomicroscopy.
Findings will be compared to histopathological and clinical results.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mucosal healing
Time Frame: up to three years
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We will determine endomicroscopic features of mucosal inflammation (e.g.
goblet cell depletion, leackage, microvessel density) in IBD in order to establish a new endoscopic classification of mucosal healing.
|
up to three years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Histologic correlation
Time Frame: up to three years
|
Comparison of clinical and histopathological data with endoscopic findings to evaluate mucosal healing as a parameter of remission and relapse in patients with IBD.
|
up to three years
|
|
Therapeutic effect
Time Frame: up to three years
|
We will evaluate the effect of different therapeutic strategies (eg.
anti-TNF treatment) on characteristics of mucosal healing (e.g.
goblet cell depletion, microvessels, leakage).
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up to three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Helmut Neumann, Professor, Department of Medicine I, University of Erlangen-Nuremberg, Germany
- Principal Investigator: Markus F. Neurath, Professor, Department of Medicine I, University of Erlangen-Nuremberg, Germany
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2011
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
August 10, 2011
First Submitted That Met QC Criteria
August 15, 2011
First Posted (Estimate)
August 16, 2011
Study Record Updates
Last Update Posted (Actual)
December 14, 2020
Last Update Submitted That Met QC Criteria
December 10, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HN-0008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.