Endomicroscopy and Graft-versus-host Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01583712|
Recruitment Status : Unknown
Verified July 2015 by Werner Dolak, MD, Medical University of Vienna.
Recruitment status was: Recruiting
First Posted : April 24, 2012
Last Update Posted : July 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Haematopoietic Stem Cell Transplantation||Procedure: Confocal laser endomicroscopy Device: Confocal Laser Endomicroscope||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnosis of Acute Gastrointestinal Graft-versus-Host Disease by Early Endomicroscopic Features of the Small Intestine|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||March 2016|
All patients included in the study will undergo endomicroscopy of the upper GI-tract including the reachable parts of the small bowel.
Procedure: Confocal laser endomicroscopy
Endomicroscopy of the upper gastrointestinal tract including endomicroscopic pictures taken every ten centimetres in the small bowel, gastric antrum, gastric corpus and esophagus.
Device: Confocal Laser Endomicroscope
Pentax EC-3870 CIFK with the ISC-1000 confocal endomicroscopy processor - Pentax, Tokyo, Japan and Optiscan Pty Ltd, Notting Hill, Victoria, Australia
- GvHD-markers on endomicroscopy [ Time Frame: 2 years ]Establishing endomicroscopic markers of acute graft-versus-host disease in the small bowel. This outcome is a qualitative endpoint. It will be assessed descriptively.
- Sensitivity and Specificity of Endomicroscopy in enteral GvHD [ Time Frame: 2 years ]At the end of the study all study derived endomicroscopic pictures will be judged by two board certified pathologists regarding presence or absence of GvHD. In comparison to the corresponding histological sections sensitivity and specificity of the technique will be calculated
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): NCT01583712
|Contact: Werner Dolak, MD||0043 1 40400 firstname.lastname@example.org|
|Contact: Andreas Puespoek, MD||0043 1 40400 email@example.com|
|Principal Investigator:||Werner Dolak, MD||Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterologie and Hepatologie|
|Study Director:||Andreas Puespoek, MD||Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology|