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)
Parallel
Needle Agitation Strategy During EBUS-TBNA
Procedure/SurgeryThe 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 of passes, suction technique, and specimen handling, are standardized.
Diagnostic Yield of EBUS-TBNA
Proportion of cases in which EBUS-TBNA provides a definitive histopathological diagnosis based on tissue specimens obtained during the procedure.
Tissue Core Length
Measured length of the tissue core specimen obtained during EBUS-TBNA, recorded in centimeters immediately after specimen collection.
Procedure-Related Complication Rate
Incidence of procedure-related complications, including bleeding, infection, pneumothorax, or other adverse events associated with EBUS-TBNA.
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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
