Endomicroscopy and Gastric MALT-lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Werner Dolak, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01583699
First received: January 8, 2012
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
MALT-lymphoma
Procedure: Confocal laser endomicroscopy
Device: Confocal Laser Endomicroscope

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
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)
Arms Assigned Interventions
Experimental: Endomicroscopy
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients referred to our department for upper endoscopy in the context of staging or follow-up of gastric MALT-lymphoma.

Exclusion criteria:

  • patients allergic to one of the drug components (including drugs used for conscious sedation like propofol or midazolam as well as fluorescein, the fluorescent dye used for CLE )
  • refusal to participate in the study
  • patient's age below 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583699

Contacts
Contact: Werner Dolak, MD 0043 1 40400 6589 werner.dolak@meduniwien.ac.at
Contact: Andreas Puespoek, MD 0043 1 40400 4739 andreas.puespoek@meduniwien.ac.at

Locations
Austria
Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology Recruiting
Vienna, Austria
Contact: Werner Dolak, MD    0043 1 40400 6589    werner.dolak@meduniwien.ac.at   
Contact: Andreas Puespoek, MD    0043 1 40400 4739    andreas.puespoek@meduniwien.ac.at   
Principal Investigator: Werner Dolak, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
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
  More Information

Publications:

Responsible Party: Werner Dolak, MD, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01583699     History of Changes
Other Study ID Numbers: EK 111/2011
Study First Received: January 8, 2012
Last Updated: January 22, 2014
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
MALT-lymphoma
Confocal laser endomicroscopy
Gastrointestinal endoscopy

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on September 16, 2014