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
90 participants
INTERVENTIONAL
2013-03-31
2014-05-31
Brief Summary
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Bronchoscopy with bronchoalveolar lavage (BAL), EBUS-TBNA, EBUS guided transbronchial forceps biopsy (EBUS-TBFB), large bore (19G) histology TBNA as well as endobronchial forceps biopsy will be performed in 90 consecutive patients with mediastinal lymph node enlargement and clinical and radiological features of sarcoidosis.
Diagnostic accuracy of each sampling technique will be calculated and compared to other techniques. Diagnostic yield of different technique combinations will also be calculated and the most efficient diagnostic approach will be defined.
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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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Bronchoscopic lymph node sampling
Several different sampling techniques will be used in each patient. They include: EBUS guided transbronchial needle aspiration (EBUS-TBNA), EBUS guided transbronchial forceps biopsy (EBUS-TBFB), large bore (19G) histologic needle biopsy of the mediastinal lymph nodes, forceps biopsy of bronchial mucosa in central and peripheral bronchi
EBUS guided transbronchial forceps biopsy (EBUS-TBFB)
EBUS guided transbronchial needle aspiration (EBUS-TBNA)
large bore (19G) histologic needle biopsy of the mediastinal lymph nodes
Bronchoalveolar lavage (BAL)
Endobronchial forceps biopsy
Interventions
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EBUS guided transbronchial forceps biopsy (EBUS-TBFB)
EBUS guided transbronchial needle aspiration (EBUS-TBNA)
large bore (19G) histologic needle biopsy of the mediastinal lymph nodes
Bronchoalveolar lavage (BAL)
Endobronchial forceps biopsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* mediastinal lymph node enlargement that requires bronchoscopy and transbronchial sampling
* clinical presentation that might be consistent with sarcoidosis
Exclusion Criteria
* known contraindications for bronchoscopy and/or mediastinal sampling, e.g. coagulation disorders
* lung or extrapulmonary tumors with suspicion of malignant mediastinal lymph node involvement
18 Years
80 Years
ALL
No
Sponsors
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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-WUM13(1)
Identifier Type: -
Identifier Source: org_study_id
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