Virtual Bronchoscopy (VB) vs. Endobronchial Ultrasound (EBUS) Guided Mediastinal Sampling
NCT ID: NCT01784185
Last Updated: 2014-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2013-01-31
2014-04-30
Brief Summary
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The diagnostic yield of the new system-assisted TBNA will be compared to the reference method (EBUS-TBNA). The study group includes patients with mediastinal mass or lymph node enlargement in whom diagnostic bronchoscopy and TBNA can be applied as diagnostic methods. Both, virtual bronchoscopy guided transbronchial needle aspiration (VB-TBNA) and EBUS-TBNA of the mediastinal targets are performed during the same diagnostic bronchoscopy. Cytologic material from VB-TBNA and EBUS-TBNA is evaluated by two independent pathologists blinded to the method used to obtain the sample. Diagnostic yield and adequacy of aspirates obtained with the two methods will be assessed and compared.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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virtual bronchoscopy guided transbronchial needle aspiration
virtual bronchoscopy guided transbronchial needle aspiration (VB-TBNA)(experimental method) and EBUS-TBNA (reference method) are performed in the same diagnostic session
virtual bronchoscopy guided transbronchial needle aspiration
endobronchial ultrasound guided transbronchial needle aspiration
endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of mediastinal lesions
Interventions
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virtual bronchoscopy guided transbronchial needle aspiration
endobronchial ultrasound guided transbronchial needle aspiration
endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of mediastinal lesions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* mediastinal mass or lymph node enlargement that requires bronchoscopy and transbronchial sampling
* quality of the CT scan which allows bronchial tree and mediastinal target segmentation and reconstruction
Exclusion Criteria
* known contraindications for bronchoscopy and/or mediastinal sampling, e.g. coagulation disorders
18 Years
ALL
No
Sponsors
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Warsaw University of Technology
OTHER
Medical University of Warsaw
OTHER
Responsible Party
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Rafał Krenke
MD, PhD
Locations
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Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IPU-DIMPA-WUM12(1)
Identifier Type: -
Identifier Source: org_study_id
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