Effect of the Number of Needle Revolutions Inside the Node on the Diagnostic Yield of EBUS-TBNA in Sarcoidosis
Condition: Sarcoidosis
MeSH terms: Sarcoidosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators plan to evaluate the effect of the number of needle revolutions inside the
      node on the diagnostic yield of endobronchial ultrasound-guided transbronchial needle
      aspiration (EBUS-TBNA) in patients with sarcoidosis.
    

Detailed description: 
      Sarcoidosis is a multisystem disorder of unknown etiology characterized by granulomatous
      inflammation involving various body organs. The diagnosis is made on the basis of compatible
      clinicoradiological feature, histopathologic evidence of non-caseating granuloma, and
      exclusion of other known causes for granulomatous inflammation. As the lung and mediastinal
      lymph nodes are the most commonly involved structures in sarcoidosis, various bronchoscopic
      techniques like endobronchial biopsy (EBB), transbronchial biopsy (TBLB) and transbronchial
      needle aspiration (TBNA) are needed for tissue sampling.

      Among the bronchoscopic techniques, TBNA of lymph nodes has emerged as the most useful
      modality in addition to the previously known endobronchial and transbronchial biopsies. The
      efficacy and safety of conventional TBNA are well established. With improvements in
      technology, last decade has seen the use of EBUS to guide transbronchial needle aspiration.
      This technique is a minimally invasive and offers the additional advantage of choosing the
      appropriate node for sampling based on the vascularity, echogenicity and size. Studies
      subsequently have demonstrated the superiority EBUS-TBNA over conventional TBNA.

      Once the role of TBNA in diagnostic bronchoscopy was clear, technical aspects of the
      procedure became the topic of research. This includes the number of aspirations or passes
      required per lymph node station, needle gauge (21 vs. 22 gauge), suction pressure, and the
      distance travelled by the needle within the lymph node. The number of revolutions i.e. the
      number of times the needle should be moved back-and-forth inside the lymph node is one such
      factor. The recommendation is to move the needle ten to twenty times. However the optimum
      number of times the needle should be moved back and forth for extracting adequate tissue
      material has not been studied to date. The investigators have observed that performing
      revolutions during EBUS-TBNA frequently leads to aspiration of blood during the procedure.

      The investigators hypothesize that the number of revolutions will not affect the diagnostic
      yield, and the yield would be similar in 10 compared to 20 revolutions. In this study, the
      investigators plan to evaluate the effect of the number of needle revolutions inside the node
      on the diagnostic yield of EBUS-TBNA in patients with sarcoidosis.
    

Intervention name(s): 10 revolutions; 20 revolutions
Intervention type(s): Procedure; Procedure
Intervention description(s): The 22G needle (Vizishot, Olympus) will be used to obtain specimens from the enlarged lymph nodes during EBUS. Once inside the lymph node, needle will be passed to and fro 10 times; The 22G needle (Vizishot, Olympus) will be used to obtain specimens from the enlarged lymph nodes during EBUS. Once inside the lymph node, needle will be passed to and fro 20 times
Intervention MeSH terms: Ivermectin; Selamectin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other