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

NCT04770948 | Completed

• 1 other identifier: SPL822
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield of EBUS-TBNA samples

  Specimen showing epithelioid cell granulomas or collection of epithelioid cells with a giant cell (or asteroid body or Schaumann body).

  6 months

Secondary Outcomes (4)

• Adequacy of EBUS-TBNA samples

  7 days

• Complication rate

  7 days

• Cough visual analog scale (VAS)

  1 day

• Operator VAS

  1 day

Study Arms (2)

19G

EXPERIMENTAL

19 gauge EBUS-TBNA needle

Device: 19 gauge needle

22G

ACTIVE COMPARATOR

22 gauge EBUS-TBNA needle

Device: 22 gauge needle

Interventions

19 gauge needle DEVICE

EBUS-TBNA performed using 19G needle

19G

22 gauge needle DEVICE

EBUS-TBNA performed using 22G needle

22G

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at least 18 years
• Clinicoradiological suspicion of sarcoidosis where EBUS-TBNA is being planned
• Enlarged bilateral hilar and/or mediastinal lymph nodes \>10 mm (any axis) on computed tomography of the chest
• Ability to provide informed consent to participate in the study.

You may not qualify if:

• Asymmetric lymph nodes
• Lymph nodes with significant hypodense areas suggestive of necrosis
• Tuberculin skin test \>10 mm
• Hypoxemia (SpO2 \<92% on FiO2 of 0.3)
• Treatment with systemic glucocorticoids for \>2 weeks in the preceding three months
• Diagnosis of sarcoidosis possible with another minimally invasive technique such as skin biopsy or peripheral lymph node biopsy
• Failure to provide informed consent.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead
• All India Institute of Medical Sciences: collaborator
• Apollo Hospitals Enterprise Limited: collaborator
• Jaipur Golden Hospital, New Delhi: collaborator
• Rajiv Gandhi Cancer Institute & Research Center, India: collaborator
• Institute of Pulmonology, Medical Research, and Development, Mumbai: collaborator
• All India Institute of Medical Sciences, Bhopal: collaborator
• Asian Institute of Gastroenterology, Hyderabad: collaborator
• Yashoda Hospitals, Hyderabad: collaborator
• City Clinic and Bhailal Amin General Hospital, Vadodara: collaborator

Study Sites (1)

PGIMER

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: March 1, 2021
• Primary Completion: February 28, 2023
• Study Completion: September 30, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

IN (1)