Status:
COMPLETED
An RCT of 19G EBUS-TBNA Needle in Suspected Sarcoidosis
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Collaborating Sponsors:
All India Institute of Medical Sciences
Apollo Hospitals Enterprise Limited
Conditions:
Sarcoidosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Sarcoidosis is an idiopathic disorder characterized by granulomatous inflammation involving various organ systems. The lung and mediastinal lymph nodes are the most commonly involved structures in sar...
Detailed Description
Sarcoidosis is an idiopathic disorder characterized by granulomatous inflammation involving various organ systems. The disease is diagnosed based on a suggestive clinicoradiological picture and the pr...
Eligibility Criteria
Inclusion
- All the following
- Age at least 18 years
- Clinicoradiological suspicion of sarcoidosis where EBUS-TBNA is being planned
- Enlarged bilateral hilar and/or mediastinal lymph nodes \>10 mm (any axis) on computed tomography of the chest
- Ability to provide informed consent to participate in the study.
Exclusion
- Patients with any of the following will be excluded
- Asymmetric lymph nodes
- Lymph nodes with significant hypodense areas suggestive of necrosis
- Tuberculin skin test \>10 mm
- Hypoxemia (SpO2 \<92% on FiO2 of 0.3)
- Treatment with systemic glucocorticoids for \>2 weeks in the preceding three months
- Diagnosis of sarcoidosis possible with another minimally invasive technique such as skin biopsy or peripheral lymph node biopsy
- Failure to provide informed consent.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04770948
Start Date
March 1 2021
End Date
September 30 2023
Last Update
November 29 2023
Active Locations (1)
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1
PGIMER
Chandigarh, India, 160012