NCT03657849

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Enlarged Lymph Nodes (Excluding Infective)

Interventions

Type	Name	Description
DEVICE	EBUS TBNA	All patients undergo EBUS TBNA with two needle sizes

Timeline

• Start date: 2018-07-18
• Primary completion: 2019-01-25
• Completion: 2019-08-31
• First posted: 2018-09-05
• Last updated: 2023-03-21
• Results posted: 2023-03-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study