Endoscopy and Endomicroscopy for Assessment of Mucosal Healing in Inflammatory Bowel Disease (IBD)
This study is not yet open for participant recruitment.
Verified January 2013 by University of Erlangen-Nürnberg Medical School
Sponsor:
University of Erlangen-Nürnberg Medical School
Information provided by (Responsible Party):
Helmut Neumann, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01524120
First received: January 23, 2012
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis |
Device: Endoscopy (EPK-i, Pentax, Tokyo, Japan) Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan) |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
Resource links provided by NLM:
Further study details as provided by University of Erlangen-Nürnberg Medical School:
Primary Outcome Measures:
- Mucosal healing [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- Histologic correlation [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Comparison of clinical and histopathological data with endoscopic and endomicroscopic findings to evaluate mucosal healing as a parameter of remission and relapse in patients with IBD.
- Therapeutic effect [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]We will evaluate the effect of different therapeutic strategies (eg. anti-TNF treatment, corticosteroids) on characteristics of mucosal healing (e.g. goblet cell depletion, microvessels, leakage) and remission and relapse rate.
Biospecimen Retention: Samples With DNA
Biopsies were taken from every patient for subsequent histological analysis.
| Estimated Enrollment: | 96 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Crohn's disease (CD)
Patients with CD and mucosal healing on endoscopy.
|
Device: 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.
|
Device: 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.
|
Device: 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.
|
Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan)
Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results.
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with Crohn´s disease and ulcerative colitis. Only patients with mucosal healing are included.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524120
Contacts
| Contact: Markus F. Neurath, M.D., Ph.D. | +49 9131 85-35000 | markus.neurath@uk-erlangen.de |
Locations
| Germany | |
| University of Erlangen-Nuremberg | Not yet recruiting |
| Erlangen, Germany, 91054 | |
| Contact: Helmut Neumann, M.D., Ph.D. +49 9131 85-35000 helmut.neumann@uk-erlangen.de | |
| Principal Investigator: Helmut Neumann, M.D., Ph.D. | |
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
| Principal Investigator: | Markus F. Neurath, M.D., Ph.D. | University of Erlangen-Nuremberg |
| Principal Investigator: | Helmut Neumann, M.D., Ph.D. | University of Erlangen-Nuremberg |
More Information
No publications provided
| Responsible Party: | Helmut Neumann, Professor, University of Erlangen-Nürnberg Medical School |
| ClinicalTrials.gov Identifier: | NCT01524120 History of Changes |
| Other Study ID Numbers: | HN-0009 |
| Study First Received: | January 23, 2012 |
| Last Updated: | January 23, 2013 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University of Erlangen-Nürnberg Medical School:
|
Mucosal healing |
Additional relevant MeSH terms:
|
Colitis Colitis, Ulcerative Crohn Disease Inflammatory Bowel Diseases Intestinal Diseases Ulcer |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013