Endomicroscopy and Gastric MALT-lymphoma
Extranodal marginal zone B-cell lymphoma (MZBL) of the mucosa associated lymphoid tissue (MALT-lymphoma) represents a distinct clinical entity and is the most common form of extranodal lymphoma, with a predilection for the stomach. About 90% of gastric MALT-lymphomas are associated with infection with Helicobacter pylori (HP) and eradication of the pathogen leads to regression of the tumor in a high percentage of patients at early tumour stages. Nevertheless, following complete remission after HP-eradication, the risk of relapse justifies lifelong follow-up examinations. Supported by recent findings at the investigators department, endoscopic controls should include a close examination of the small bowel, as relapses can involve different gastrointestinal sites. To continue the investigators diagnostic approach as well as to further improve the detection rate of MALT-lymphoma relapses, the investigators plan to introduce the novel confocal laser endomicroscope (CLE) into the diagnostic management of MALT-lymphoma patients. In the context of a prospective clinical pilot trial the investigators aim to establish MALT-lymphoma specific CLE-markers that can be used for the in vivo diagnosis of the disease. Comparing endomicroscopic findings, drawn from the stomach and small bowel of 50 MALT-lymphoma patients who will undergo staging or follow up endoscopies at the investigators department, to the histological evaluation of biopsy samples as present gold standard, the investigators want to determine whether CLE can provide reliable data for the accurate detection of MALT-lymphoma associated changes. Endomicroscopic aspects of patients with chronic gastritis, gastric adenocarcinoma and healthy subjects should serve as controls. In comparison to random biopsies which represent the current standard, the investigators aim to prove, whether endomicroscopy will find MALT-lymphoma lesions more accurately and thus help to spare patients unnecessary biopsies.
Procedure: Confocal laser endomicroscopy
Device: Confocal Laser Endomicroscope
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Confocal Laser Endomicroscopy as Diagnostic Tool for Gastrointestinal MALT-lymphoma|
- Qualitative MALT-features on Endomicroscopy [ Time Frame: 2 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
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
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583699
|Contact: Werner Dolak, MD||0043 1 40400 firstname.lastname@example.org|
|Contact: Andreas Puespoek, MD||0043 1 40400 email@example.com|
|Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology||Recruiting|
|Contact: Werner Dolak, MD 0043 1 40400 6589 firstname.lastname@example.org|
|Contact: Andreas Puespoek, MD 0043 1 40400 4739 email@example.com|
|Principal Investigator: Werner Dolak, MD|
|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|