Overview

This trial is active, not recruiting.

Condition sarcoidosis
Treatments ebus-tbna, conventional tbna, endobronchial and transbronchial biopsy
Sponsor Postgraduate Institute of Medical Education and Research
Start date January 2012
End date October 2013
Trial size 100 participants
Trial identifier NCT01908868, 1Trg/PG-2012/12563-601

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
EBUS-TBNA (with endobronchial and transbronchial lung biopsy)
ebus-tbna
Mediastinal and hilar lymph node aspiration using endobronchial ultrasound
endobronchial and transbronchial biopsy
Endobronchial and transbronchial lung biopsy using flexible bronchoscopy
(Active Comparator)
Conventional TBNA (with endobronchial and transbronchial lung biopsy)
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

Primary Outcomes

Measure
Diagnostic yield
time frame: 18 months

Secondary Outcomes

Measure
Safety
time frame: 18 months
Diagnostic yield of individual sampling techniques
time frame: 18 months

Eligibility Criteria

Male or female participants from 15 years up to 75 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Postgraduate Institute of Medical Education and Research.