Endomicroscopy and Gastric MALT-lymphoma

Summary

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.

Conditions

• MALT-lymphoma

Interventions

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

Sponsors & Collaborators

• Medical University of Vienna

  lead OTHER

Principal Investigators

• Werner Dolak, MD · Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterologie and Hepatologie

• Andreas Puespoek, m · Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology

• Markus Raderer, MD · Medical University of Vienna, Department of Internal Medicine I, Division of Oncology

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2014-03-31

Completion

2014-03-31

Countries

• Austria

Study Locations