Clinical Trial: Endomicroscopy and Gastric MALT-lymphoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Confocal Laser Endomicroscopy as Diagnostic Tool for Gastrointestinal MALT-lymphoma

Brief 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.

Detailed Summary:

Introduction

Extranodal marginal zone B-cell lymphoma (MZBL) of the mucosa associated lymphoid tissue (MALT-lymphoma) is the most common form of extranodal lymphoma [1, 2]. Although MALT-lymphoma may involve different organs, the stomach represents the site of predilection of this malignant disease. About 90% of gastric MALT-lymphomas are associated with infection with Helicobacter pylori (HP) [3] and eradication of the pathogen leads to tumor regression in a high percentage of patients at early tumor stages [4, 5]. Relapses after HP-eradication and primary advanced tumor stages require chemotherapeutic treatment, radiation therapy and, in some cases, surgery [6]. Following complete remission lifelong follow-up examinations should be performed in order to detect relapses [7].

Histologically, MALT-lymphoma is characterized by an infiltration of the lamina propria by lymphomatous centrocyte-like cells that spread into the surrounding mucosal layers [8]. In immunohistochemistry they show CD 20 positive staining properties. When they spread to lymph nodes or spleen they accumulate typically within the marginal zone (for this reason they are classified as "marginal zone lymphoma") [2]. Dissemination to other organs, especially to other mucosal sites may occur frequently wherefore detailed diagnostics are required during MALT-lymphoma staging and follow-up. Spreading within the gastrointestinal tract (GI-tract), to the small bowel, for example, is rare, but can be assessed very easily with standard endoscopic procedures as recently reported at our department [9].

For gastric MALT-lymphoma gastroscopy with biopsy assessment is the current follow-up examination of choice. Multiple biopsies should be taken randomly from all gastric sites and specifically from all suspiciou
Sponsor: Medical University of Vienna

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: January 8, 2012
Date Started: April 2012
Date Completion:
Last Updated: July 19, 2015
Last Verified: July 2015