A Trial to Compare Two Methods of Obtaining Tissue for Diagnosis of Sarcoidosis Namely the Conventional Method or the Ultrasound Guided Method
NCT ID: NCT02472808
Last Updated: 2015-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2015-06-30
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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cTBNA without ROSE
Patients who will undergo conventional TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
cTBNA without ROSE
Patients will undergo conventional TBNA and endobronchial biopsy and transbronchial lung biopsy
cTBNA with ROSE
Patients who will undergo conventional TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
cTBNA with ROSE
Patients will undergo conventional TBNA with rapid on site evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy
EBUS-TBNA without ROSE
Patients who will undergo EBUS-TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
EBUS-TBNA without ROSE
Patients will undergo EBUS-TBNA and endobronchial biopsy and transbronchial lung biopsy
EBUS-TBNA with ROSE
Patients who will undergo EBUS-TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
EBUS-TBNA with ROSE
Patients will undergo EBUS-TBNA with rapid onsite evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy
Interventions
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cTBNA without ROSE
Patients will undergo conventional TBNA and endobronchial biopsy and transbronchial lung biopsy
cTBNA with ROSE
Patients will undergo conventional TBNA with rapid on site evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy
EBUS-TBNA without ROSE
Patients will undergo EBUS-TBNA and endobronchial biopsy and transbronchial lung biopsy
EBUS-TBNA with ROSE
Patients will undergo EBUS-TBNA with rapid onsite evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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All India Institute of Medical Sciences
OTHER
Responsible Party
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Dr. Ashesh Dhungana
Senior Resident, Department of Pulmonary Medicine and Sleep Disorders
Principal Investigators
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Ashesh Dhungana, MD
Role: PRINCIPAL_INVESTIGATOR
All India Institute of Medical Sciences
Locations
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All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DM Thesis
Identifier Type: -
Identifier Source: org_study_id
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