A Trial to Compare Two Methods of Obtaining Tissue for Diagnosis of Sarcoidosis Namely the Conventional Method or the Ultrasound Guided Method
- Conditions
- Sarcoidosis
- Interventions
- Other: cTBNA without ROSEOther: EBUS-TBNA without ROSEOther: cTBNA with ROSEOther: EBUS-TBNA with ROSE
- Registration Number
- NCT02472808
- Lead Sponsor
- All India Institute of Medical Sciences, New Delhi
- 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.
- Detailed Description
This study is investigator initiated, prospective, unblinded randomized study comparing conventional TBNA with EBUS-TBNA for obtaining tissue samples from mediastinal lymph nodes for the diagnosis of sarcoidosis when combined with transbronchial lung biopsy and endobronchial biopsy. It will be conducted on 80 consecutive patients with suspected sarcoidosis presenting to Department of Pulmonary Medicine and Sleep Disorders in AIIMS (All India Institute of Medical Sciences), New Delhi. This study will help to know whether EBUS (Endobronchial Ultrasound guided) or conventional TBNA is better for obtaining tissue samples from mediastinal lymph nodes for the diagnosis of sarcoidosis. It will also help to know the value of adding rapid onsite evaluation of the cytology smears to both the procedures. It will also help to determine the overall yield of different procedures when they are combined for obtaining tissue samples for a diagnosis of sarcoidosis.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cTBNA without ROSE cTBNA without ROSE Patients who will undergo conventional TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy EBUS-TBNA without ROSE EBUS-TBNA without ROSE Patients who will undergo EBUS-TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy cTBNA with ROSE cTBNA with ROSE Patients who will undergo conventional TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy EBUS-TBNA with ROSE EBUS-TBNA with ROSE Patients who will undergo EBUS-TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
- Primary Outcome Measures
Name Time Method Diagnostic Yield of Conventional TBNA vs EBUS TBNA with or without ROSE 6 months 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
- Secondary Outcome Measures
Name Time Method 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 Specificity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis 6 months Specificity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis 6 months Negative predictive value of EBUS-TBNA in the diagnosis of Sarcoidosis 6 months Yield of EBUS-TBNA in Conventional TBNA with or without ROSE negative patients 6 months 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
Specificity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis 6 months Specificity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis 6 months Positive predictive value of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis 6 months Negative predictive value of conventional TBNA in the diagnosis of Sarcoidosis 6 months Negative predictive value of conventional TBNA when combined with ROSE in the diagnosis of Sarcoidosis 6 months Positive predictive value of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis 6 months Negative predictive value of EBUS-TBNA when combined with ROSE in the diagnosis of Sarcoidosis 6 months Positive predictive value of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis 6 months Positive predictive value of EBUS-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
Trial Locations
- Locations (1)
All India Institute of Medical Sciences
🇮🇳New Delhi, Delhi, India