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
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
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)
Phan Quang Hieu
Lead sponsor
University Medical Center Ho Chi Minh City (UMC)
Sponsor institution
University of Medicine and Pharmacy at Ho Chi Minh City
Collaborator