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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Completed

Conditions: Sarcoidosis

Treatments: Other: Conventional TBNA; Other: EBUS-TBNA; Other: Endobronchial and transbronchial biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01908868

1Trg/PG-2012/12563-601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

EBUS-TBNA

Experimental group

Description:

EBUS-TBNA (with endobronchial and transbronchial lung biopsy)

Treatment:

Other: EBUS-TBNA

Other: Endobronchial and transbronchial biopsy

Conventional TBNA

Active Comparator group

Description:

Conventional TBNA (with endobronchial and transbronchial lung biopsy)

Treatment:

Other: Conventional TBNA

Other: Endobronchial and transbronchial biopsy