Endomicroscopy and Gastric MALT-lymphoma
|ClinicalTrials.gov Identifier: NCT01583699|
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : July 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|MALT-lymphoma||Procedure: Confocal laser endomicroscopy Device: Confocal Laser Endomicroscope||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Confocal Laser Endomicroscopy as Diagnostic Tool for Gastrointestinal MALT-lymphoma|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
All patients included into the study will undergo endomicroscopy of the upper GI-tract.
Procedure: Confocal laser endomicroscopy
Endomicroscopy of the upper gastrointestinal tract to capture endomicroscopic pictures from the small bowel, stomach 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
- Qualitative MALT-features on Endomicroscopy [ Time Frame: 2 years ]Establishing endomicroscopic features of MALT-lymphoma in the upper gastrointestinal tract. This outcome is a qualitative endpoint that will be assessed only descriptively.
- Sensitivity and Specificity of Endomicroscopy to diagnose GI-MALT-Lymphoma [ Time Frame: 2 years ]At the end of the study, endomicroscopic pictures gained during the study will be assessed by two blinded pathologists regarding judgement on MALT-lymphoma presence or absence. The results will be compared to the corresponding histological sections in order to calculate sensitivity ans specificity for the technique.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01583699
|Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology|
|Principal Investigator:||Werner Dolak, MD||Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterologie and Hepatologie|
|Study Director:||Andreas Puespoek, m||Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology|
|Study Chair:||Markus Raderer, MD||Medical University of Vienna, Department of Internal Medicine I, Division of Oncology|