A Study Evaluating the Diagnostic Yield and Safety of the ProCore vs Conventional EBUS-TBNA Needle in Subjects With Suspected Sarcoidosis
Condition: Sarcoidosis
MeSH terms: Sarcoidosis
Study type: Interventional

Summary: 
      This study evaluates the yield and safety of two different needles for performing
      endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) in patients with
      sarcoidosis. The two needles that will be compared will be the 22-gauge ProCore needle and
      the conventional 22-gauge EBUS-TBNA needle.
    

Detailed description: 
      Sarcoidosis is a multisystem disorder of unknown cause characterized by granulomatous
      inflammation involving various organ systems. The diagnosis is made on the basis of a
      suggestive clinicoradiological picture, 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 is a useful modality especially when
      combined with endobronchial and transbronchial biopsies. The efficacy and safety of
      conventional TBNA are well established. With the advent of endobronchial ultrasound (EBUS) in
      the last decade, this new technology has been widely used to guide transbronchial needle
      aspiration. The technique is 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 of EBUS-TBNA over conventional TBNA.

      As EBUS-TBNA is the standard procedure now for accessing intrathoracic lymph nodes, the
      technical aspects of the procedure need further investigation. Several aspects 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, and the distance
      travelled by the needle within the lymph node.

      The EchoTip ProCore High Definition ultrasound biopsy needle (Cook Medical Inc., Bloomington,
      Ind., USA) is a novel needle that has been used mainly in sampling intra-abdominal lesions.
      It has a special bevel which allows a core biopsy along with aspiration of the lymph node
      material. In case of mediastinal lymph node enlargement due to malignancy, needle aspiration
      alone may yield sufficient material to identify malignant cells. However, in sarcoidosis, the
      core biopsy specimen obtained with the ProCore needle may potentially increase the
      identification of granulomas. The investigators hypothesize that the 22-gauge ProCore needle
      will have a higher yield in diagnosing intrathoracic lymphadenopathy due to sarcoidosis as
      compared to the conventional 22-gauge EBUS-TBNA needle. In this study, the investigators plan
      to evaluate the yield and safety of the 22-gauge ProCore needle as compared to the
      conventional 22-gauge EBUS-TBNA needle in patients with sarcoidosis.
    

Intervention name(s): Procore biopsy needle; Conventional biopsy needle
Intervention type(s): Device; Device
Intervention description(s): EBUS-TBNA with the EchoTip ProCore needle (Cook Medical Inc., Bloomington, Ind., USA); EBUS-TBNA with the conventional 22-gauge EBUS-TBNA needle (Vizishot, Olympus, Japan)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic