An RCT of 19G EBUS-TBNA Needle in Suspected Sarcoidosis

Summary

Sarcoidosis is an idiopathic disorder characterized by granulomatous inflammation involving various organ systems. The lung and mediastinal lymph nodes are the most commonly involved structures in sarcoidosis. In the presence of intrathoracic lymph nodes, transbronchial needle aspiration (TBNA) is a useful diagnostic modality, which is now guided using endobronchial ultrasound (EBUS).

We hypothesize that the 19-gauge EBUS-TBNA needle will have a higher yield as compared to the conventional 22-gauge EBUS-TBNA needle in intrathoracic lymphadenopathy due to sarcoidosis. In this study, we plan to evaluate the yield and safety of the 19-gauge needle vs. the conventional 22-gauge EBUS-TBNA needle in patients with sarcoidosis.

Conditions

• Sarcoidosis

Interventions

DEVICE

19 gauge needle

EBUS-TBNA performed using 19G needle

DEVICE

22 gauge needle

EBUS-TBNA performed using 22G needle

Sponsors & Collaborators

• All India Institute of Medical Sciences

  collaborator OTHER

• Apollo Hospitals Enterprise Limited

  collaborator OTHER

• Jaipur Golden Hospital, New Delhi

  collaborator UNKNOWN

• Rajiv Gandhi Cancer Institute & Research Center, India

  collaborator OTHER

• Institute of Pulmonology, Medical Research, and Development, Mumbai

  collaborator UNKNOWN

• All India Institute of Medical Sciences, Bhopal

  collaborator OTHER

• Asian Institute of Gastroenterology, Hyderabad

  collaborator UNKNOWN

• Yashoda Hospitals, Hyderabad

  collaborator UNKNOWN

• City Clinic and Bhailal Amin General Hospital, Vadodara

  collaborator UNKNOWN

• Post Graduate Institute of Medical Education and Research, Chandigarh

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-01

Primary Completion

2023-02-28

Completion

2023-09-30

Countries

• India

Study Locations