A Trial of EBUS-TBNA Versus Conventional TBNA in Diagnosis of Sarcoidosis
1 other identifier
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 16, 2013
CompletedFirst Posted
Study publicly available on registry
July 26, 2013
CompletedDecember 30, 2014
December 1, 2014
1.1 years
July 16, 2013
December 26, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Safety
18 months
Diagnostic yield of individual sampling techniques
18 months
Study Arms (2)
EBUS-TBNA
EXPERIMENTALEBUS-TBNA (with endobronchial and transbronchial lung biopsy)
Conventional TBNA
ACTIVE COMPARATORConventional TBNA (with endobronchial and transbronchial lung biopsy)
Interventions
Mediastinal and hilar lymph node aspiration using blind transbronchial needle aspiration
Endobronchial and transbronchial lung biopsy using flexible bronchoscopy
Eligibility Criteria
You may qualify if:
- Consecutive patients presenting with clinicoradiological features suggestive of sarcoidosis and an indication for transbronchial needle aspiration
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chest Clinic, PGIMER
Chandigarh, 160012, India
Related Publications (1)
Gupta D, Dadhwal DS, Agarwal R, Gupta N, Bal A, Aggarwal AN. Endobronchial ultrasound-guided transbronchial needle aspiration vs conventional transbronchial needle aspiration in the diagnosis of sarcoidosis. Chest. 2014 Sep;146(3):547-556. doi: 10.1378/chest.13-2339.
PMID: 24481031DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 16, 2013
First Posted
July 26, 2013
Study Start
November 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
December 30, 2014
Record last verified: 2014-12