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

Sarcoidosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908868
• Other study ID #: 1Trg/PG-2012/12563-601
• Status: Completed
• Phase: N/A
• First received: July 16, 2013
• Last updated: December 26, 2014
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2014
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Dept of Pulmonary Medicine
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Other:
• EBUS-TBNA
Mediastinal and hilar lymph node aspiration using endobronchial ultrasound
• Conventional TBNA
Mediastinal and hilar lymph node aspiration using blind transbronchial needle aspiration
• Endobronchial and transbronchial biopsy
Endobronchial and transbronchial lung biopsy using flexible bronchoscopy

Locations

Country	Name	City	State
India	Chest Clinic, PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety	Occurrence of serious adverse events (pneumothorax, bleeding >100 ml, death) in the two groups	18 months	Yes
Secondary	Diagnostic yield of individual sampling techniques	To study the diagnostic yield of EBUS-TBNA, conventional TBNA, TBLB and EBB	18 months	No