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The guided FNA by endobronchial ultrasound ( Endobronchial Ultrasound guided transbronchial Needle Aspiration or EBUS-TBNA) is a minimally invasive technique with an established role in the staging of lung cancer 1, and in the evaluation of intrathoracic lymph node metastases from extrathoracic primary cancer2 . There is also a role in cases of isolated hilar and mediastinal lymph nodes in which the differential diagnosis includes mostly sarcoidosis, lymphoma and tuberculosis. 3
Various studies have evaluated more recently the diagnostic yield of EBUS-TBNA specifically for sarcoidosis 4 and thoracic lymphoma 5-6. Although there is emerging data supporting the usefulness of EBUS-TBNA in the investigation of these two pathologies, the efficacy results vary according to the target populations and certain parameters. Moreover, although a large randomized study demonstrated e superiority of EBUS-TBNA over conventional bronchoscopic sampling methods [ bronchoalveolar lavage (BAL) and trans-bronchial biopsies (TBB ] for the diagnosis of sarcoidosis , 7 the results suggest that there is still room for optimizing the performance of EBUS-TBNA [b] . In the field of lymphoma, obtaining large enough specimens for adequate subtyping also remains a concern. 8
In order to improve the performance of EBUS -TBNA , new needles have been developed with the aim to provide biopsies for histological evaluation rather than purely cytological. The ViziShot FLEX © (Olympus) 19 gauge needle (19 gauge or 19G) is a large needle, which can provide both tissue and needle aspiration , and has the advantage of being more flexible.
For this study, the investigators want to compare the diagnostic yield of EBUS-TBNA using needle ViziShot FLEX 19G (1.11 mm) with that of the standard 22G needle ( NA-201SX; Olympus) , in the investigation of hilar or mediastinal lymphadenopathy suspected to be sarcoidosis or lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vizishot Flexneedle 19G | Experimental | Mediastinal and hilar lymph node sampling using the Vizishot Flexneedle19G EBUS-TBNA needle |
|
| Vizishot 22G | Active Comparator | Mediastinal and hilar lymph node sampling using a standard Vizishot 22G EBUS-TBNA needle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ViziShot FLEX 19G needle | Device | EBUS-TBNA using the ViziShot FLEX 19G needle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield of EBUS-TBNA | The diagnostic yield of EBUS TBNA with 19G and 22G needle in patients with a final diagnosis of sarcoidosis will be assessed for any difference between the two, using McNemar test on paired proportions. | 12 months after enrollment of the last patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of use. | Evaluate the ease of use of both types of needles. Using a visual analog scale (from 0 most difficult to 10 very easy to use), ease of use of each needle will be assessed and compared for each lymph node. | 1 week after enrollment of last patient. |
| Specimen quality |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Vandemoortele, MD, MSc | Contact | 514-890-8000 | 25151 | thomas.vandemoortele@me.com |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Vandemoortele, MD, MSc | CHUM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier de l'Université de Montréal (CHUM) | Recruiting | Montreal | Quebec | H2X 3E4 | Canada |
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| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
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| ID | Term |
|---|---|
| D009339 | Needles |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Vizishot 22G needle (standard) |
| Device |
EBUS-TBNA using the Vizishot 22G needle (standard) |
|
Samples will be considered adequate if the cytologic assessment shows lymphocytes and or definite if the specimen shows epithelioid cell granulomas or collection of epithelioid cells with a giant cell (or asteroid body or Schaumann body). The samples will be classified as: diagnostic, adequate but non-diagnostic, non-diagnostic and not adequate, no specimen |
| 1 week after enrollment of last patient |
| Complications | Complications encountered with both needle sizes will be compared if there is any difference in the rate of complications, specifically pneumothorax, endobronchial bleeding, post-bronchoscopy bleeding, pneumonia, respiratory infection, hospitalization required because of the procedure, respiratory failure, death. | 1 month after enrollment of last patient |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007160 | Immunoproliferative Disorders |