A Trial to Compare Two Methods of Obtaining Tissue for Diagnosis of Sarcoidosis Namely the Conventional Method or the Ultrasound Guided Method

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Diagnostic Utility of EBUS-TBNA Versus Conventional TBNA With Rapid on Site Evaluation in the Diagnosis of Sarcoidosis: a Randomised Study

Conditions
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Sarcoidosis

Intervention / Treatment
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* Other: cTBNA without ROSE
* Other: cTBNA with ROSE
* Other: EBUS-TBNA without ROSE
* Other: EBUS-TBNA with ROSE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: cTBNA without ROSE<br>Patients who will undergo conventional TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy | Other: cTBNA without ROSE<br>* Patients will undergo conventional TBNA and endobronchial biopsy and transbronchial lung biopsy<br>|
| Other: cTBNA with ROSE<br>Patients who will undergo conventional TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy | Other: cTBNA with ROSE<br>* Patients will undergo conventional TBNA with rapid on site evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy<br>|
| Other: EBUS-TBNA without ROSE<br>Patients who will undergo EBUS-TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy | Other: EBUS-TBNA without ROSE<br>* Patients will undergo EBUS-TBNA and endobronchial biopsy and transbronchial lung biopsy<br>|
| Other: EBUS-TBNA with ROSE<br>Patients who will undergo EBUS-TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy | Other: EBUS-TBNA with ROSE<br>* Patients will undergo EBUS-TBNA with rapid onsite evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |