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

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 |

Arm | Intervention/treatment |
---|---|
Experimental: Endomicroscopy
All patients included into the study will undergo endomicroscopy of the upper GI-tract.
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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
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- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Austria | |
Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology | |
Vienna, Austria |
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 |
Publications:
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 |