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

Enlarged Lymph Nodes (Excluding Infective) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03657849
• Other study ID #: A18-177
• Status: Completed
• Phase: N/A
• Start date: July 18, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: August 2019
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 31, 2019
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enlarged Lymph Nodes (Excluding Infective)
• Lymphadenopathy

Intervention

Device:
• EBUS TBNA
All patients undergo EBUS TBNA with two needle sizes

Locations

Country	Name	City	State
United States	Regions Hospital	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Yield	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%	6 months
Primary	Diagnostic Yield	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).	6 months