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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bronchoscopic lymph node sampling | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBUS guided transbronchial forceps biopsy (EBUS-TBFB) | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of different bronchoscopic sampling methods in making the diagnosis of sarcoidosis. | 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. | Approximately ten days after the procedure, when the results of the cytological and histopathological examination will be available |
| Measure | Description | Time Frame |
|---|---|---|
| Adequacy of cytologic and histopathologic specimens collected by different sampling method as the diagnostic samples enabling confirmation of granulomatous lymph node disease. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Local complications of mediastinal lymph node sampling | 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 | During and 24 hrs after bronchoscopic procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rafal Krenke, MD, PhD | Contact | rafalkrenke@interia.pl | ||
| Piotr Korczynski, MD, PhD | Contact | drkorczynski@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw | Recruiting | Warsaw | 02-097 | Poland |
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| EBUS guided transbronchial needle aspiration (EBUS-TBNA) | Procedure |
|
| large bore (19G) histologic needle biopsy of the mediastinal lymph nodes | Procedure |
|
| Bronchoalveolar lavage (BAL) | Procedure |
|
| Endobronchial forceps biopsy | Procedure |
|
| up to 9 months |
| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| D014376 | Tuberculosis |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007160 | Immunoproliferative Disorders |
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| ID | Term |
|---|---|
| D018893 | Bronchoalveolar Lavage |
| ID | Term |
|---|---|
| D007507 | Therapeutic Irrigation |
| D008919 | Investigative Techniques |
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