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