Sarcoidosis
Conditions
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.
Interventions
OTHERcTBNA without ROSE
Patients will undergo conventional TBNA and endobronchial biopsy and transbronchial lung biopsy
OTHERcTBNA with ROSE
Patients will undergo conventional TBNA with rapid on site evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy
OTHEREBUS-TBNA without ROSE
Patients will undergo EBUS-TBNA and endobronchial biopsy and transbronchial lung biopsy
OTHEREBUS-TBNA with ROSE
Patients will undergo EBUS-TBNA with rapid onsite evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy
Sponsors
All India Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Specificity of conventional TBNA 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 | — |
| 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 |
| 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 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 | — |
Other
| Measure | Time frame |
|---|---|
| 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 |
| Specificity of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis | 6 months |
| Sensitivity of endobronchial biopsy to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis | 6 months |
Countries
India
Contacts
Primary ContactAshesh Dhungana, MD
Backup ContactRandeep Guleria, DM
Outcome results
None listed