Mediastinal Lymph Node Enlargement, Sarcoidosis, Tuberculosis, Lymphomas
Conditions
Keywords
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)
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.
Interventions
PROCEDUREEBUS guided transbronchial forceps biopsy (EBUS-TBFB)
PROCEDUREEBUS guided transbronchial needle aspiration (EBUS-TBNA)
PROCEDURElarge bore (19G) histologic needle biopsy of the mediastinal lymph nodes
PROCEDUREBronchoalveolar lavage (BAL)
PROCEDUREEndobronchial forceps biopsy
Sponsors
Medical University of Warsaw
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of different bronchoscopic sampling methods in making the diagnosis of sarcoidosis. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Comparison of the number of patients in whom the specific sampling method has been undertaken (e.g. BAL, EBUS-TBNA, EBUS-TBFB and large bore TBNA) with the number of patients in whom the specific sampling method provided the adequate specimens, containing the elements of granulomas (also the relationship between the mediastinal lymph node dimension and the quality of the samples collected with different techniques) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Local complications of mediastinal lymph node sampling | During and 24 hrs after bronchoscopic procedure | The number of patients in whom mediastinal vessels would be injured (resulting in endobronchial or extrabronchial bleeding). The number of patients with pneumothorax and/or pneumomediastinum complicating mediastinal sampling |
Countries
Poland
Contacts
Primary ContactRafal Krenke, MD, PhD
Backup ContactPiotr Korczynski, MD, PhD
Outcome results
None listed