Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03656003 |
Other study ID # |
Int/IEC/2018/00169 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 1, 2018 |
Est. completion date |
July 31, 2019 |
Study information
Verified date |
February 2021 |
Source |
Postgraduate Institute of Medical Education and Research |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.