Trial Information
Diagnostic Accuracy of Different Bronchoscopic Sampling Techniques in Patients With Mediastinal Lymph Node Enlargement Suspected of Sarcoidosis
Inclusion Criteria:
- provided informed consent
- mediastinal lymph node enlargement that requires bronchoscopy and transbronchial
sampling
- clinical presentation that might be consistent with sarcoidosis
Exclusion Criteria:
- age below 18 years
- known contraindications for bronchoscopy and/or mediastinal sampling, e.g.
coagulation disorders
- lung or extrapulmonary tumors with suspicion of malignant mediastinal lymph node
involvement
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
Outcome Measure:
Accuracy of different bronchoscopic sampling methods in making the diagnosis of sarcoidosis.
Outcome Description:
Comparison of the diagnostic yield of the cytologic and histologic specimens collected by EBUS-TBNA , EBUS-TBFB and large bore TBNA in terms of making the diagnosis of sarcoidosis.
Outcome Time Frame:
Approximately ten days after the procedure, when the results of the cytological and histopathological examination will be available
Safety Issue:
No
Authority:
Poland: Bioethics Appeals Commission
Study ID:
IPU-DIMPA-WUM13(1)
NCT ID:
NCT01836822
Start Date:
March 2013
Completion Date:
October 2013
Related Keywords:
- Mediastinal Lymph Node Enlargement
- Sarcoidosis
- Tuberculosis
- Lymphomas
- mediastinal lymph node enlargement
- sarcoidosis
- bronchoscopy
- EBUS guided transbronchial needle aspiration (EBUS-TBNA)
- transbronchial needle aspiration (EBUS-TBNA)
- EBUS guided transbronchial forceps biopsy EBUS-TBFB)
- Hypertrophy
- Lymphoma
- Sarcoidosis
- Tuberculosis
- Lymphatic Diseases