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

N/ACompletedNCT01908868

Post Graduate Institute of Medical Education and Research, Chandigarh130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

130

Conditions

Sarcoidosis

Interventions

EBUS-TBNAOTHER

Mediastinal and hilar lymph node aspiration using endobronchial ultrasound

Conventional TBNAOTHER

Mediastinal and hilar lymph node aspiration using blind transbronchial needle aspiration

Endobronchial and transbronchial biopsyOTHER

Endobronchial and transbronchial lung biopsy using flexible bronchoscopy

Eligibility

Sex: ALLMin age: 15 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Chest Clinic, PGIMER

Chandigarh, India

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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