Evaluation of 19-gauge vs 21-gauge EBUS… | Clinical Trial

Key information

Conditions

Enlarged Lymph Nodes (Excluding Infective) Hemic and Lymphatic Diseases Lymphadenopathy Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EBUS TBNA

Device

All patients undergo EBUS TBNA with two needle sizes

Primary outcomes

Diagnostic Yield

Time frame: 6 months

Diagnostic yield refers to the proportion of tissue samples collected by each needle (19 gauge vs 21 gauge) that were of sufficient quantity and quality to yield (i.e. produce) an accurate diagnosis for the patient's enlarged lymph nodes. Characterization of diagnostic category (true positive, true negative, false negative, false positive) were made by comparing the patient's presumed diagnosis/initial indication for presentation in comparison to their final diagnosis as determined by a combination of pathological findings of EBUS-TBNA, follow up imaging, surgical sampling, or clinical follow up. The diagnostic yield of each needles was reported as a ratio of true positives and true negatives added together, divided by the total number of lymph nodes sampled (141).

Diagnostic yield of 19-gauge needle: 89.4% Diagnostic yield of 21-gauge needled: 88.7%
Diagnostic Yield

Time frame: 6 months

Diagnostic yield refers to the proportion of tissue samples collected by each needle (19 gauge vs 21 gauge) that were of sufficient quantity and quality to yield (i.e. produce) an accurate diagnosis for the patient's enlarged lymph nodes. Characterization of diagnostic category (true positive, true negative, false negative, false positive) were made by comparing the patient's presumed diagnosis/initial indication for presentation in comparison to their final diagnosis as determined by a combination of pathological findings of EBUS-TBNA, follow up imaging, surgical sampling, or clinical follow up. The diagnostic yield of each needles was reported as a ratio of true positives and true negatives added together, divided by the total number of lymph nodes sampled (141).

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Sep 5, 2018
Registry last updated: Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed