Comparison of Two Needle Agitation Strategies in Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) for Diagnostic Yield

Official title

A Randomized, Single-Blind Controlled Trial Comparing Two Needle Agitation Strategies During Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration for Diagnostic Yield in Patients With Enlarged Mediastinal Lymph Nodes

Overview

The goal of this clinical trial is to learn whether the number of needle agitations during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) affects diagnostic yield in patients with enlarged mediastinal lymph nodes. The study will also evaluate tissue sample quality and the safety of different needle agitation strategies. The main questions it aims to answer are: Does the number of needle agitations improve diagnostic yield? Does a higher number of needle agitations increase tissue core length and specimen adequacy? Are there differences in procedure-related complications between the two needle agitation strategies? Researchers will compare two needle agitation strategies during EBUS-TBNA to see if one approach provides better diagnostic performance, improved sample quality, and similar procedural safety. Participants will: * Undergo EBUS-TBNA as part of their clinical evaluation * Be randomly assigned to one of two needle agitation strategies * Have tissue samples measured for core length and assessed for diagnostic adequacy * Be monitored for procedure-related complications

Detailed description

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has become the standard minimally invasive modality for sampling mediastinal lymph nodes in patients with suspected thoracic malignancies and benign lymphadenopathies. Despite its widespread adoption and high overall diagnostic performance, variability in procedural techniques may contribute to heterogeneity in specimen quality and diagnostic yield.

Among procedural factors, the number of needle agitations performed during each needle pass represents a modifiable technical variable that may influence tissue acquisition. Increased needle agitation may theoretically enhance tissue yield and core length by promoting mechanical dissection of nodal tissue; however, excessive agitation may also increase blood contamination, reduce sample interpretability, or elevate procedural trauma risk. Conversely, fewer agitations may limit tissue disruption but potentially result in inadequate sampling. Currently, there is no high-level evidence establishing an optimal agitation strategy, and operator-dependent variability remains common in clinical practice.

This randomized, single-blind controlled trial is designed to compare two predefined needle agitation strategies during EBUS-TBNA. By standardizing all other procedural variables, the study aims to isolate the effect of agitation number on diagnostic performance. Objective procedural metrics, including measured tissue core length and specimen adequacy, will be systematically assessed to provide quantitative evaluation of sample quality. Procedural safety outcomes will also be monitored to evaluate whether differences in agitation strategy influence complication rates.

The results of this trial are expected to provide evidence-based data to support technical standardization of EBUS-TBNA and to inform procedural guidelines aimed at optimizing diagnostic efficiency while maintaining safety.

Interventions

• Procedure Needle Agitation Strategy During EBUS-TBNA
  The intervention consists of modifying the number of needle agitations performed during each needle pass in endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). Participants are randomized to one of two predefined agitation strategies: a low-range strategy (10 to fewer than 30 agitations per pass, target approximately 20) or a high-range strategy (30 to 60 agitations per pass, target approximately 45 to 50). All other procedural variables, including needle type, number o

Primary outcome measures

• Diagnostic Yield of EBUS-TBNA [Time frame: Within 7-14 days after the procedure]

Secondary outcome measures (1)

• Tissue Core Length [Time frame: Immediately after the procedure]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years
• Presence of enlarged mediastinal or hilar lymph nodes requiring diagnostic evaluation on chest computed tomography (CT), defined as short-axis diameter ≥ 10 mm measured on axial images
• Clinical indication for EBUS-TBNA
• Ability to provide written informed consent

Exclusion criteria

• Uncorrected coagulation disorders (platelet count < 100,000/mm³; International normalized ratio (INR) > 1.5; or prothrombin time < 50% of control)
• Acute myocardial infarction within the preceding 4 weeks or ongoing unstable angina
• Significant upper airway obstruction (benign or malignant) with ≥ 50% reduction in tracheal lumen diameter
• Hemodynamic instability (e.g., persistent hypotension, significant arrhythmia, or need for vasopressors)
• Respiratory failure refractory to oxygen therapy, defined as sustained Peripheral oxygen saturation (SpO₂) ≤ 90% despite supplemental oxygen
• Intractable cough precluding bronchoscopy
• History of severe allergy to local anesthetics or sedative agents used during the procedure
• Refusal or inability to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Diagnostic

Study locations

Vietnam · 1 center

• University Medical Center Ho Chi Minh City — Ho Chi Minh City

Identifiers

NCT: NCT07424807 · UMP-EBUS-2026-01 · IRB-VN01002/IRB00010293

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗