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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
80
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
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
RECRUITINGDiagnostic 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
Time frame: 6 months
Yield of EBUS-TBNA in Conventional TBNA with or without ROSE negative patients
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
Time frame: 6 months
Sensitivity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
Sensitivity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
Sensitivity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
Sensitivity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
Specificity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
Specificity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
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Patients will undergo EBUS-TBNA with rapid onsite evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy
Specificity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
Specificity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
Positive predictive value of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
Positive predictive value of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
Positive predictive value of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
Positive predictive value of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
Time frame: 6 months
Negative predictive value of conventional TBNA in the diagnosis of Sarcoidosis
Time frame: 6 months
Negative predictive value of conventional TBNA when combined with ROSE in the diagnosis of Sarcoidosis
Time frame: 6 months
Negative predictive value of EBUS-TBNA in the diagnosis of Sarcoidosis
Time frame: 6 months
Negative predictive value of EBUS-TBNA when combined with ROSE in the diagnosis of Sarcoidosis
Time frame: 6 months