Sarcoidosis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHEREBUS-TBNA
Mediastinal and hilar lymph node aspiration using endobronchial ultrasound
OTHERConventional TBNA
Mediastinal and hilar lymph node aspiration using blind transbronchial needle aspiration
OTHEREndobronchial and transbronchial biopsy
Endobronchial and transbronchial lung biopsy using flexible bronchoscopy
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Consecutive patients presenting with clinicoradiological features suggestive of sarcoidosis and an indication for transbronchial needle aspiration
Exclusion criteria
* Pregnancy * Hypoxemia (SpO2 \<90%) on room air * Poor lung function (forced expiratory volume in first second \[FEV1\] \<1L) * Patients with deranged clotting profile (prothrombin time \>3 seconds above control; activated partial thromboplastin time \>10 seconds above control, platelet count \<50000/µL) * Patients already initiated on glucocorticoids * Diagnosis of sarcoidosis possible on minimally invasive techniques such as skin biopsy or peripheral lymph node biopsy and failure to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | 18 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 18 months | Occurrence of serious adverse events (pneumothorax, bleeding \>100 ml, death) in the two groups |
| Diagnostic yield of individual sampling techniques | 18 months | To study the diagnostic yield of EBUS-TBNA, conventional TBNA, TBLB and EBB |
Countries
India
Outcome results
None listed