An RCT of 19G EBUS-TBNA Needle in Suspected Sarcoidosis

Study Overview
=================
Brief Summary
-----------------
Sarcoidosis is an idiopathic disorder characterized by granulomatous inflammation involving various organ systems. The lung and mediastinal lymph nodes are the most commonly involved structures in sarcoidosis. In the presence of intrathoracic lymph nodes, transbronchial needle aspiration (TBNA) is a useful diagnostic modality, which is now guided using endobronchial ultrasound (EBUS). We hypothesize that the 19-gauge EBUS-TBNA needle will have a higher yield as compared to the conventional 22-gauge EBUS-TBNA needle in intrathoracic lymphadenopathy due to sarcoidosis. In this study, we plan to evaluate the yield and safety of the 19-gauge needle vs. the conventional 22-gauge EBUS-TBNA needle in patients with sarcoidosis.

Detailed Description
-----------------
Sarcoidosis is an idiopathic disorder characterized by granulomatous inflammation involving various organ systems. The disease is diagnosed based on a suggestive clinicoradiological picture and the presence of non-caseating granulomas in the involved organ, after excluding known causes of granulomatous inflammation. The lung and mediastinal lymph nodes are the most commonly involved structures in sarcoidosis. Various bronchoscopic techniques such as endobronchial biopsy (EBB), transbronchial biopsy (TBLB) and transbronchial needle aspiration (TBNA) are commonly used for acquiring tissue samples. In the presence of intrathoracic lymph nodes, TBNA is a useful diagnostic modality, especially when combined with endobronchial and transbronchial biopsies. At most centers, TBNA is now guided using endobronchial ultrasound (EBUS). The technique is minimally invasive and also offers the advantage of a selection of the appropriate node for sampling based on the ultrasonographic characteristics. Several studies have demonstrated the superiority of EBUS-TBNA over conventional TBNA (TBNA performed without real-time guidance). Several technical aspects of EBUS-TBNA have been studied to optimize the yield including the number of aspirations or passes required per lymph node station, needle gauge (21 vs. 22 gauge), suction pressure, the distance travelled by the needle within the lymph node, the number of needle agitations required during a pass, and others. The novel 19-G Vizishot FLEX EBUS needle (Olympus) is composed of a more flexible material (nitinol) than the 22-G EBUS needle. This allows it to have a larger inner diameter with the same outer diameter as a 22-G EBUS needle. Recent studies have shown that the 19-G needle is safe and has a comparable yield to smaller bore needles. In case of suspected lymphadenopathy due to malignant disorders, aspiration using smaller gauge needles may yield sufficient material for diagnosis. However, in sarcoidosis, larger nodal tissue obtained with a thicker bore needle, the 19-gauge needle, may potentially increase the identification of granulomas. We hypothesize that the 19-gauge EBUS-TBNA needle will have a higher yield as compared to the conventional 22-gauge EBUS-TBNA needle in intrathoracic lymphadenopathy due to sarcoidosis. In this study, we plan to evaluate the yield and safety of the 19-gauge needle vs. the conventional 22-gauge EBUS-TBNA needle in patients with sarcoidosis.

Official Title
-----------------
A Study Evaluating the Diagnostic Yield and Safety of the 19-GaUge vs 22-Gauge EBUS-TBNA Needle in Subjects With Suspected Sarcoidosis (GUESS)

Conditions
-----------------
Sarcoidosis

Intervention / Treatment
-----------------
* Device: 19 gauge needle
* Device: 22 gauge needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the following Age at least 18 years Clinicoradiological suspicion of sarcoidosis where EBUS-TBNA is being planned Enlarged bilateral hilar and/or mediastinal lymph nodes >10 mm (any axis) on computed tomography of the chest Ability to provide informed consent to participate in the study. Exclusion Criteria: Patients with any of the following will be excluded Asymmetric lymph nodes Lymph nodes with significant hypodense areas suggestive of necrosis Tuberculin skin test >10 mm Hypoxemia (SpO2 <92% on FiO2 of 0.3) Treatment with systemic glucocorticoids for >2 weeks in the preceding three months Diagnosis of sarcoidosis possible with another minimally invasive technique such as skin biopsy or peripheral lymph node biopsy Failure to provide informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 19G<br>19 gauge EBUS-TBNA needle | Device: 19 gauge needle<br>* EBUS-TBNA performed using 19G needle<br>|
| Active Comparator: 22G<br>22 gauge EBUS-TBNA needle | Device: 22 gauge needle<br>* EBUS-TBNA performed using 22G needle<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield of EBUS-TBNA samples | Specimen showing epithelioid cell granulomas or collection of epithelioid cells with a giant cell (or asteroid body or Schaumann body). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of EBUS-TBNA samples | Specimen shows a preponderance of lymphocytes or is diagnostic | 7 days | 
| Complication rate | Complication associated with EBUS-TBNA procedure | 7 days | 
| Cough visual analog scale (VAS) | Operator-rated visual analog scale (VAS) score for the intensity of subject's cough | 1 day | 
| Operator VAS | VAS score for ease of performance of the needle puncture and aspiration rated by the operator | 1 day |