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The main objective of this study is to determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy.
Background:
Diarrhea is characterized by frequent, loose, and watery bowel movements. Common causes include various gastrointestinal infections (e.g. clostridium difficile, salmonella), inflammatory bowel disease (ulcerative colitis, Crohn´s disease), drugs (e.g. antibiotics) and malabsorption syndromes (e.g. celiac and Whipple's disease). 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.
Scope:
In patients with diarrhea.
Methods:
Patients were randomized in two groups. Group 1: Patients underwent standard video colonoscopy for the evaluation of their symptoms. Group 2: During the endoscopic procedure CLE will be performed additionally.
Procedure:
The patient underwent colonoscopy. In Group 2 patients´ will receive intravenous fluorescein or topical mucosal staining with acriflavin or cresyl violet during the procedure, followed by in-vivo CLE of the tissue. Confocal images are digitally saved and analyzed afterwards.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Patients with diarrhea undergoing endoscopy | Standard video colonoscope. |
| |
| Group 2: Patients with diarrhea undergoing endoscopy. | Confocal laser endomicroscopy (CLE). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy | Procedure | Patients will undergo colonoscopy for evaluation of their symptoms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy. | February 2012 |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate whether CLE has a higher sensitivity and specificity than standard colonoscopy in the diagnosis of the cause of diarrhea. | February 2012 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients of a tertiary referral hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Markus F. Neurath, M.D., Ph.D. | Department of Medicine I, University of Erlangen-Nuremberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erlangen | 91054 | Germany |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| Confocal Laser Endomicroscopy | Procedure | Patients will undergo CLE during their endoscopy. Findings will be compared to group 1. |
|
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |