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

Not Applicable

Completed

• Conditions: Sarcoidosis
• Interventions: Other: Conventional TBNA; Other: EBUS-TBNA; Other: Endobronchial and transbronchial biopsy

• Registration Number: NCT01908868
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-07-16
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-26
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-26
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional TBNA	Conventional TBNA	Conventional TBNA (with endobronchial and transbronchial lung biopsy)
EBUS-TBNA	Endobronchial and transbronchial biopsy	EBUS-TBNA (with endobronchial and transbronchial lung biopsy)
Conventional TBNA	Endobronchial and transbronchial biopsy	Conventional TBNA (with endobronchial and transbronchial lung biopsy)
EBUS-TBNA	EBUS-TBNA	EBUS-TBNA (with endobronchial and transbronchial lung biopsy)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chest Clinic, PGIMER; 🇮🇳 Chandigarh, India