A Trial of EBUS-TBNA Versus Conventional TBNA in Diagnosis of Sarcoidosis

Study Overview
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Brief Summary
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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
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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.

Conditions
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Sarcoidosis

Intervention / Treatment
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* Other: EBUS-TBNA
* Other: Conventional TBNA
* Other: Endobronchial and transbronchial biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EBUS-TBNA<br>EBUS-TBNA (with endobronchial and transbronchial lung biopsy) | Other: EBUS-TBNA<br>* Mediastinal and hilar lymph node aspiration using endobronchial ultrasound<br>Other: Endobronchial and transbronchial biopsy<br>* Endobronchial and transbronchial lung biopsy using flexible bronchoscopy<br>|
| Active Comparator: Conventional TBNA<br>Conventional TBNA (with endobronchial and transbronchial lung biopsy) | Other: Conventional TBNA<br>* Mediastinal and hilar lymph node aspiration using blind transbronchial needle aspiration<br>Other: Endobronchial and transbronchial biopsy<br>* Endobronchial and transbronchial lung biopsy using flexible bronchoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Occurrence of serious adverse events (pneumothorax, bleeding >100 ml, death) in the two groups | 18 months | 
| Diagnostic yield of individual sampling techniques | To study the diagnostic yield of EBUS-TBNA, conventional TBNA, TBLB and EBB | 18 months |