NCT03657849

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

Completed NA Results posted Last updated 21 March 2023

What this trial tests

NA trial testing EBUS TBNA in Enlarged Lymph Nodes (Excluding Infective) in 60 participants. Completed in 31 August 2019.

Timeline

18 July 2018

Primary endpoint
25 January 2019

31 August 2019

Quick facts

Lead sponsor	HealthPartners Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	60
Start date	18 July 2018
Primary completion	25 January 2019
Estimated completion	31 August 2019
Sites	1 location across United States

Drugs / interventions tested

• EBUS TBNA

Conditions studied

• Enlarged Lymph Nodes (Excluding Infective) — all drugs for Enlarged Lymph Nodes (Excluding Infective) →

Sponsor

HealthPartners Institute

Who can join

18 and older, any sex, with Enlarged Lymph Nodes (Excluding Infective). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Diagnostic Yield Primary · 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

Group	Value	95% CI
19-Gauge Needle	69
21-Gauge Needle	68
19-Gauge Needle	57
21-Gauge Needle	57
19-Gauge Needle	15
21-Gauge Needle	16

Diagnostic Yield Primary · 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

Group	Value	95% CI
19-Gauge Needle	126
21-Gauge Needle	125

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected from the time the patient signed the consent form (i.e. immediately prior to the Endobronchial ultrasound (EBUS) transbronchial needle aspiration (TBNA) procedure), to the point at which the results of the confirmed and a final diagnosis was reported to the participant. Although the follow-up period varied by participant, the average length of time over which adverse events tracked and reported was 6 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

19-Gauge Needle Used First

Serious: 1/30 (3%)

Deaths: 0/30

21-Gauge Needle Used First

Serious: 2/30 (7%)

Deaths: 1/30

Serious adverse events (3 terms)

Reaction	System	19-Gauge Needle Used First	21-Gauge Needle Used First
respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
acute hypoxic respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Missing 19-guage needle spring	Injury, poisoning and procedural complications	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	19-Gauge Needle Used First	21-Gauge Needle Used First
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—
Blood clot	Respiratory, thoracic and mediastinal disorders	—	—
Hypotension	Injury, poisoning and procedural complications	—	—
Nausea/Vertigo	Gastrointestinal disorders	—	—
Bleeding	Injury, poisoning and procedural complications	—	—
poor ventilation	Injury, poisoning and procedural complications	—	—

Most-reported serious reactions: respiratory failure, acute hypoxic respiratory failure, Missing 19-guage needle spring.

Data from ClinicalTrials.gov NCT03657849 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.