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

All India Institute Of Medical Science (AIIMS)

Status: Unknown

Conditions: Sarcoidosis

Treatments: Other: cTBNA without ROSE; Other: EBUS-TBNA without ROSE; Other: cTBNA with ROSE; Other: EBUS-TBNA with ROSE

Study type: Interventional

Funder types: Other

Identifiers

NCT02472808

DM Thesis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

cTBNA without ROSE

Other group

Description:

Patients who will undergo conventional TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy

Treatment:

Other: cTBNA without ROSE

cTBNA with ROSE

Other group

Description:

Patients who will undergo conventional TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy

Treatment:

Other: cTBNA with ROSE

EBUS-TBNA without ROSE

Other group

Description:

Patients who will undergo EBUS-TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy

Treatment:

Other: EBUS-TBNA without ROSE

EBUS-TBNA with ROSE

Other group

Description:

Patients who will undergo EBUS-TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy

Treatment:

Other: EBUS-TBNA with ROSE