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Endomicroscopy and Gastric MALT-lymphoma

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ClinicalTrials.gov Identifier: NCT01583699
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):
Werner Dolak, MD, Medical University of Vienna

Study Description
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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.

Condition or disease Intervention/treatment Phase
MALT-lymphoma Procedure: Confocal laser endomicroscopy Device: Confocal Laser Endomicroscope Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01583699


Locations
Austria
Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology
Vienna, Austria
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
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Publications:
Kiesslich R, Galle P, Neurath M. Atlas of endomicroscopy. Springer Medical Publishing. 2008

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

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

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