Evaluation of 19-gauge vs 21-gauge EBUS TBNA in Assessing Thoracic Lymphadenopathy

HealthPartners Institute

Status: Completed

Conditions: Enlarged Lymph Nodes (Excluding Infective)

Treatments: Device: EBUS TBNA

Study type: Interventional

Funder types: Other

Identifiers

NCT03657849

A18-177

Details and patient eligibility

About

This study compares the yield of 19-gauge needles vs 21-gauge needles during EBUS TBNA procedures.

Full description

Endobronchial ultrasound-guided transbronchial needle aspirate (EBUS-TBNA) is a technique used to take samples of body tissue inside the chest without having to undergo an operation.

During this procedure, a special telescope (called a bronchoscope) is inserted through the mouth into the airways. Ultrasound technology allows the doctor to see the structures just outside the airway. By being able to see the structures outside the airway, the doctor is able to safely pass a fine needle through the airway to take samples of abnormal tissue.

EBUS-TBNA is used to take samples of tissue from the mediastinum. The mediastinum is the part of the chest between the lungs, and contains the heart, gullet, windpipe and lymph nodes. This area of the body is usually difficult to access without open surgery, hence the use of EBUS-TBNA. EBUS-TBNA may be used to investigate enlarged lymph nodes. This may be due to tuberculosis, sarcoidosis or cancer.

Currently, smaller 21-gauge and larger 19-gauge needles are used during the EBUS-TBNA procedure at Regions Hospital. The purpose of this study is to find out which needle is better in finding the explanation for the enlarged lymph nodes, and any follow up procedures that may be necessary if the investigators are unable to get enough tissue during the EBUS-TBNA procedure (surgical sampling, radiological sampling, and/or follow-up imaging).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older
• Able to provide informed consent
• Referred for EBUS TBNA sampling at Regions Hospital

Exclusion criteria

• On therapeutic warfarin, Plavix, or ticagrelor in the past 5 days
• INR>1.8 or platelets <50K

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Sampling with 19-gauge and 21-gauge

Experimental group

Description:

All patients will be allocated to the same arm. All patients will have EBUS TBNA done with both 19-gauge and 21-gauge needles during the procedure.

Treatment:

Device: EBUS TBNA