N/A N=61 Randomized Double-blind Diagnostic

Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Using a 22 vs 25-Gauge Needle

Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma · Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT03004586 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: Primary: Percentage of Lymph Nodes With Adequate Samples — 79; 78.5 Percentage of Lymph Nodes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 25-Gauge Needle (Device); 22-Gauge Needle (Device); Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Jun 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Lymph Nodes With Adequate Samples	79; 78.5	—
SECONDARY Concordance With the Final Diagnosis	82; 80.5	—
SECONDARY Usability of the Needle	4.27; 4.95; 4.58; 4.00; 4.40; 4.65	—

Summary

The goal of this clinical research study is to compare the effectiveness of a smaller, 25-gauge needle when used in an endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) instead of a standard 22-gauge needle. The safety of the needles will also be studied.

Eligibility Criteria

Inclusion Criteria

Age 18 years or older
Indication for EBUS-guided needle biopsy based on suspicion of either benign or malignant disease in mediastinal or hilar lymph nodes.

Exclusion Criteria

Patients who are pregnant or lactating
Inability to give informed consent
Patients in which only one lymph node station is expected to be sampled by the performing clinician.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03004586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.