Clinical trial NCT02472808: A Trial to Compare Two Methods of Obtaining Tissue for Diagnosis of Sarcoidosis Namely the Conventional Method or the Ultrasound Guided Method
Official title: Diagnostic Utility of EBUS-TBNA Versus Conventional TBNA With Rapid on Site Evaluation in the Diagnosis of Sarcoidosis: a Randomised Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcoidosis
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Yield of Conventional TBNA vs EBUS TBNA with or without ROSE
timeFrame: 6 months
Secondary outcomes:
measure: Yield of EBUS-TBNA in Conventional TBNA with or without ROSE negative patients
timeFrame: 6 months
measure: Sensitivity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Sensitivity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Sensitivity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Sensitivity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Specificity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Specificity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Specificity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Specificity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Positive predictive value of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Positive predictive value of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Positive predictive value of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Positive predictive value of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Negative predictive value of conventional TBNA in the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Negative predictive value of conventional TBNA when combined with ROSE in the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Negative predictive value of EBUS-TBNA in the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Negative predictive value of EBUS-TBNA when combined with ROSE in the diagnosis of Sarcoidosis
timeFrame: 6 months
Other outcomes:
measure: Sensitivity of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Specificity of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Positive predictive value of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Negative predictive value of endobronchial biopsy in the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Sensitivity of transbronchial lung biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Specificity of transbronchial lung biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Positive predictive value of transbronchial lung biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis
timeFrame: 6 months
measure: Negative predictive value of transbronchial lung biopsy in the diagnosis of Sarcoidosis
timeFrame: 6 months
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: Ashesh Dhungana, MD
role: PRINCIPAL_INVESTIGATOR
References: