A Trial to Compare Two Methods of Obtaining Tissue for Diagnosis of Sarcoidosis Namely the Conventional Method or the Ultrasound Guided Method
Diagnostic Utility of EBUS-TBNA Versus Conventional TBNA With Rapid on Site Evaluation in the Diagnosis of Sarcoidosis: a Randomised Study
1 other identifier
interventional
80
1 country
1
Brief Summary
This trial compares the yield of cTBNA (conventional Transbronchial Needle Aspiration) versus the EBUS-TBNA (Endobronchial Ultrasound guided TBNA) for obtaining cytology when they are combined with endobronchial biopsy and transbronchial lung biopsy and rapid onsite examination (ROSE) of the obtained smears in the diagnosis of suspected sarcoidosis patients visiting our hospital for evaluation of mediastinal lymphadenopathy.
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 Jun 2015
Shorter than P25 for not_applicable
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
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 7, 2015
CompletedFirst Posted
Study publicly available on registry
June 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJuly 7, 2015
June 1, 2015
7 months
June 7, 2015
July 6, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic Yield of Conventional TBNA vs EBUS TBNA with or without ROSE
Diagnostic Yield is defined as the number of patients with presence of non caseating granuloma on cytology smear divided by total number of sarcoidosis patient expressed as percentage
6 months
Secondary Outcomes (17)
Yield of EBUS-TBNA in Conventional TBNA with or without ROSE negative patients
6 months
Sensitivity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
6 months
Sensitivity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
6 months
Sensitivity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
6 months
Sensitivity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
6 months
- +12 more secondary outcomes
Other Outcomes (8)
Sensitivity of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
6 months
Specificity of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
6 months
Positive predictive value of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
6 months
- +5 more other outcomes
Study Arms (4)
cTBNA without ROSE
OTHERPatients who will undergo conventional TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
cTBNA with ROSE
OTHERPatients who will undergo conventional TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
EBUS-TBNA without ROSE
OTHERPatients who will undergo EBUS-TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
EBUS-TBNA with ROSE
OTHERPatients who will undergo EBUS-TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
Interventions
Patients will undergo conventional TBNA and endobronchial biopsy and transbronchial lung biopsy
Patients will undergo conventional TBNA with rapid on site evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy
Patients will undergo EBUS-TBNA and endobronchial biopsy and transbronchial lung biopsy
Patients will undergo EBUS-TBNA with rapid onsite evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy
Eligibility Criteria
You may qualify if:
- Age \> 18 years and suspected Stage 1 (mediastinal or hilar Lymphadenopathy (LAP)) or Stage 2 ( LAP and parenchymal abnormalities) sarcoidosis
- Significant mediastinal LAP (Short Axis Diameter more than 10mm)
- Lymph Node (LN) enlargement in station 4, 7, 10 or 11 and CT chest findings consistent with sarcoidosis.
- With or without supportive evidence of sarcoidosis - hypercalcemia, calciuria, raised ACE levels or restriction/obstruction on Pulmonary Function Tests (PFT).
You may not qualify if:
- Obvious other organ involvement with possibility to confirm granuloma with minimally invasive diagnostic procedure (Skin biopsy, superficial lymph nodes, Lofgren's Syndrome)
- Sarcoidosis Stage 3 and 4
- Mediastinal Nodes less than 10 mm in short axis diameter
- Absence of right paratracheal and subcarinal Lymph node enlargement more than 1 cm in short axis diameter
- Those who received empiric Steroid for \>2 weeks in preceding 3 months
- Contraindication to bronchoscopy and TBNA (Coagulopathy, Hypoxemia)
- Unwilling to give consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110016, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashesh Dhungana, MD
All India Institute of Medical Sciences
Central Study Contacts
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
- Senior Resident, Department of Pulmonary Medicine and Sleep Disorders
Study Record Dates
First Submitted
June 7, 2015
First Posted
June 16, 2015
Study Start
June 1, 2015
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
July 7, 2015
Record last verified: 2015-06