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

NCT ID: NCT02472808

Last Updated: 2015-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-01-31

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.

Conditions

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Sarcoidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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cTBNA without ROSE

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

Group Type OTHER

cTBNA without ROSE

Intervention Type OTHER

Patients will undergo conventional TBNA and endobronchial biopsy and transbronchial lung biopsy

cTBNA with ROSE

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

Group Type OTHER

cTBNA with ROSE

Intervention Type 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

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

Group Type OTHER

EBUS-TBNA without ROSE

Intervention Type OTHER

Patients will undergo EBUS-TBNA and endobronchial biopsy and transbronchial lung biopsy

EBUS-TBNA with ROSE

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

Group Type OTHER

EBUS-TBNA with ROSE

Intervention Type OTHER

Patients will undergo EBUS-TBNA with rapid onsite evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy

Interventions

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cTBNA without ROSE

Patients will undergo conventional TBNA and endobronchial biopsy and transbronchial lung biopsy

Intervention Type OTHER

cTBNA with ROSE

Patients will undergo conventional TBNA with rapid on site evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy

Intervention Type OTHER

EBUS-TBNA without ROSE

Patients will undergo EBUS-TBNA and endobronchial biopsy and transbronchial lung biopsy

Intervention Type OTHER

EBUS-TBNA with ROSE

Patients will undergo EBUS-TBNA with rapid onsite evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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All India Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ashesh Dhungana

Senior Resident, Department of Pulmonary Medicine and Sleep Disorders

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashesh Dhungana, MD

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

Locations

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All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Ashesh Dhungana, MD

Role: CONTACT

00919953586175

Randeep Guleria, DM

Role: CONTACT

00919810184738

Facility Contacts

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Ashesh Dhungana, MD

Role: primary

09953586175

Randeep Guleria, DM

Role: backup

09810184738

Other Identifiers

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DM Thesis

Identifier Type: -

Identifier Source: org_study_id

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