Endoscopy and Endomicroscopy for Assessment of Mucosal Healing in Inflammatory Bowel Disease (IBD)
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ClinicalTrials.gov Identifier: NCT01524120 |
Recruitment Status
: Unknown
Verified January 2013 by Helmut Neumann, University of Erlangen-Nürnberg Medical School.
Recruitment status was: Not yet recruiting
First Posted
: February 1, 2012
Last Update Posted
: January 24, 2013
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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 or disease | Intervention/treatment |
---|---|
Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis | Device: Endoscopy (EPK-i, Pentax, Tokyo, Japan) Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan) |
Study Type : | Observational |
Estimated Enrollment : | 96 participants |
Time Perspective: | Prospective |
Study Start Date : | April 2012 |
Estimated Primary Completion Date : | March 2015 |
Estimated Study Completion Date : | March 2015 |

Group/Cohort | Intervention/treatment |
---|---|
Crohn's disease (CD)
Patients with CD and mucosal healing on endoscopy.
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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.
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Crohn's disease
Patients with CD and mucosal healing on endomicroscopy.
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Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan)
Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results.
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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.
|
- Mucosal healing [ Time Frame: 3 years ]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.
- Histologic correlation [ Time Frame: 3 years ]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 ]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.
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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524120
Contact: Markus F. Neurath, M.D., Ph.D. | +49 9131 85-35000 | markus.neurath@uk-erlangen.de |
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. |
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 |
Responsible Party: | Helmut Neumann, Professor, University of Erlangen-Nürnberg Medical School |
ClinicalTrials.gov Identifier: | NCT01524120 History of Changes |
Other Study ID Numbers: |
HN-0009 |
First Posted: | February 1, 2012 Key Record Dates |
Last Update Posted: | January 24, 2013 |
Last Verified: | January 2013 |
Keywords provided by Helmut Neumann, University of Erlangen-Nürnberg Medical School:
Mucosal healing |
Additional relevant MeSH terms:
Crohn Disease Colitis, Ulcerative Intestinal Diseases Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Colitis Colonic Diseases |