Diagnostic Accuracy of Different Bronchoscopic Sampling Techniques in Patients With Mediastinal Lymph Node Enlargement Suspected of Sarcoidosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mediastinal Lymph Node Enlargement
- Sponsor
- Medical University of Warsaw
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Accuracy of different bronchoscopic sampling methods in making the diagnosis of sarcoidosis.
- Last Updated
- 12 years ago
Overview
Brief Summary
The development of endobronchial ultrasound (EBUS) and EBUS-guided transbronchial needle aspiration (EBUS-TBNA) has improved the safety and diagnostic accuracy of the mediastinal lymph node (MLN) sampling. Still, in some diseases routine cytological specimens are considered insufficient and histological sampling is preferred. The aim of the study is to compare the diagnostic accuracy of EBUS-TBNA and two other, more invasive procedures to obtain histological samples from MLN in patients with clinical and radiological features of sarcoidosis.
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.
Investigators
Rafał Krenke
MD, PhD
Medical University of Warsaw
Eligibility Criteria
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
Outcomes
Primary Outcomes
Accuracy of different bronchoscopic sampling methods in making the diagnosis of sarcoidosis.
Time Frame: Approximately ten days after the procedure, when the results of the cytological and histopathological examination will be available
Comparison of the diagnostic yield of the cytologic and histologic specimens collected by EBUS-TBNA, EBUS-TBFB, large bore TBNA, endobronchial forceps biopsy and BAL in terms of making the diagnosis of sarcoidosis.
Secondary Outcomes
- Adequacy of cytologic and histopathologic specimens collected by different sampling method as the diagnostic samples enabling confirmation of granulomatous lymph node disease.(up to 9 months)