An interventional study of EBUS-TBNA and Conventional TBNA in Sarcoidosis, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Completed at 1 site in India. Open to participants aged 15 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-12-30.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Not applicable, Interventional, and Diagnostic
The investigators hypothesize that conventional or EBUS-TBNA will have equal efficiency in diagnosing sarcoidosis when performed in conjunction with endobronchial and transbronchial lung biopsy.
Diagnostic procedures like transbronchial lung biopsy (TBLB), transbronchial needle aspiration (TBNA) and endobronchial biopsy (EBB) are routinely used to obtain pathological confirmation of pulmonary sarcoidosis. Real-time convex probe endobronchial ultrasound-guided TBNA (EBUS-TBNA) has shown immense potential, however it is costly, labor intensive and still has limited availability, especially in low and middle income countries. In the past, TBLB has been the bronchoscopic procedure of choice for diagnosis of sarcoidosis however currently its role is being debated with the advent of EBUS. We have observed that EBUS even though has high yield yet the optimal diagnosis is obtained only when combined with EBB and TBLB. The investigators hypothesize that conventional or EBUS-TBNA will have equal efficiency in diagnosing sarcoidosis when performed in conjunction with endobronchial and transbronchial lung biopsy.
The study compares the diagnostic yield of EBUS-TBNA (plus EBB and TBLB) vs. conventional TBNA (plus EBB and TBLB) for diagnosis of sarcoidosis.
278 studies on the registry are indexed under Sarcoidosis; 57 are open to participants now.
This study's enrollment of 130 is above the median of 54 across 154 interventional studies indexed under Sarcoidosis.
Browse Sarcoidosis studies →Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 290 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients presenting with clinicoradiological features suggestive of sarcoidosis and an indication for transbronchial needle aspiration
Exclusion Criteria:
EBUS-TBNA (with endobronchial and transbronchial lung biopsy)
Other: EBUS-TBNA · Other: Endobronchial and transbronchial biopsy
Conventional TBNA (with endobronchial and transbronchial lung biopsy)
Other: Conventional TBNA · Other: Endobronchial and transbronchial biopsy
Mediastinal and hilar lymph node aspiration using endobronchial ultrasound
Mediastinal and hilar lymph node aspiration using blind transbronchial needle aspiration
Endobronchial and transbronchial lung biopsy using flexible bronchoscopy
Diagnostic yield
The primary outcome is the diagnostic yield of the procedure defined as demonstration of granulomatous inflammation in two groups in patients finally labelled as sarcoidosis
Time frame: 18 months
Safety
Occurrence of serious adverse events (pneumothorax, bleeding \>100 ml, death) in the two groups
Time frame: 18 months
Diagnostic yield of individual sampling techniques
To study the diagnostic yield of EBUS-TBNA, conventional TBNA, TBLB and EBB
Time frame: 18 months
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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Post Graduate Institute of Medical Education and Research, Chandigarh