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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cTBNA without ROSE | Other | Patients who will undergo conventional TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy |
|
| cTBNA with ROSE | Other | Patients who will undergo conventional TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy |
|
| EBUS-TBNA without ROSE | Other | Patients who will undergo EBUS-TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy |
|
| EBUS-TBNA with ROSE | Other | Patients who will undergo EBUS-TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cTBNA without ROSE | Other | Patients will undergo conventional TBNA and endobronchial biopsy and transbronchial lung biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Sensitivity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashesh Dhungana, MD | Contact | 00919953586175 | asheshdhungana12@gmail.com | |
| Randeep Guleria, DM | Contact | 00919810184738 | randeepguleria2002@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Ashesh Dhungana, MD | All India Institute of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All India Institute of Medical Sciences | Recruiting | New Delhi | National Capital Territory of Delhi | 110016 | India |
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| cTBNA with ROSE | Other | Patients will undergo conventional TBNA with rapid on site evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy |
|
| EBUS-TBNA without ROSE | Other | Patients will undergo EBUS-TBNA and endobronchial biopsy and transbronchial lung biopsy |
|
| EBUS-TBNA with ROSE | Other | Patients will undergo EBUS-TBNA with rapid onsite evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy |
|
| 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 |
| Specificity of conventional TBNA 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 |
| Specificity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for 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 conventional 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 |
| Positive predictive value of EBUS-TBNA when combined with ROSE 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 |
| Negative predictive value of EBUS-TBNA in 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 endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis | 6 months |
| Negative predictive value of endobronchial biopsy in the diagnosis of Sarcoidosis | 6 months |
| Sensitivity of transbronchial lung biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis | 6 months |
| Specificity of transbronchial lung biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis | 6 months |
| Positive predictive value of transbronchial lung biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis | 6 months |
| Negative predictive value of transbronchial lung biopsy in the diagnosis of Sarcoidosis | 6 months |
| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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