RecruitingNot Applicable

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

Vietnam180 participantsStarted 2026-02-16

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Diagnostic Yield of EBUS-TBNA

Timeframe: Within 7-14 days after the procedure

Trial details

NCT IDNCT07424807

SponsorPhan Quang Hieu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09

Contact for this trial

Hieu Q Phan, MD, M.Sc.

+84907718538 hieu.pq@umc.edu.vn