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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopy (EPK-i, Pentax, Tokyo, Japan) | Device | Patients will undergo white-light endoscopy. Any mucosal lesions will be recorded and findings will be compared to histopathological and clinical results. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Histologic correlation | 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. | 3 years |
| Therapeutic effect |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Crohn´s disease and ulcerative colitis. Only patients with mucosal healing are included.
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| Name | Affiliation | Role |
|---|---|---|
| Markus F. Neurath, M.D., Ph.D. | University of Erlangen-Nürnberg | Principal Investigator |
| Helmut Neumann, M.D., Ph.D. | University of Erlangen-Nürnberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Erlangen-Nuremberg | Erlangen | 91054 | Germany |
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Biopsies were taken from every patient for subsequent histological analysis.
| Endomicroscopy (iCLE, Pentax, Tokyo, Japan) | Device | Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results. |
|
| Endoscopy (EPK-i, Pentax, Tokyo, Japan) | Device | 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) | Device | Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results. |
|
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.
| 3 years |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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