Comparing more versus fewer needle agitations during EBUS-TBNA for mediastinal lymph node biopsy
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
Run by University Medical Center Ho Chi Minh City (UMC) · NCT07424807 · Data updated 2026-11-12
This test will see if using more or fewer needle agitations during EBUS-guided needle biopsies helps doctors obtain longer tissue cores and higher-quality samples in adults with enlarged mediastinal lymph nodes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | University Medical Center Ho Chi Minh City (UMC) Academic / other |
| Locations | 1 site (Ho Chi Minh City, Ho Chi Minh) |
| Status | Recruiting |
| Started | February 16, 2026 |
| Main results expected | September 2028 |
| Study ends | December 2028 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT07424807 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with enlarged mediastinal or hilar lymph nodes (short-axis ≥10 mm) who are scheduled for clinically indicated EBUS-TBNA and can provide informed consent.
✕Probably not a fit
Patients with uncorrected bleeding disorders, recent myocardial infarction or unstable cardiac status, severe airway obstruction, hemodynamic instability, respiratory failure, intractable cough, or other contraindications to bronchoscopy are unlikely to benefit because they are excluded or unsafe to enroll.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults needing EBUS-TBNA for enlarged mediastinal or hilar lymph nodes (short-axis ≥10 mm) will be randomized to one of two predefined needle agitation strategies during each needle pass. Operators will standardize other procedural variables while pathologists blinded to allocation will measure outcomes including diagnostic yield, tissue core length, specimen adequacy, and procedure-related complications. The trial is single-blind and focuses on objective specimen metrics and safety events to isolate the effect of agitation number. Findings will determine whether changing the number of needle agitations improves sample quality or alters procedural risk.
Why it matters
Potential benefit: If successful, the preferred agitation method could increase diagnostic yield and reduce repeat biopsies by producing longer, more adequate tissue cores without raising complication rates.
How similar studies have gone: There is limited high-quality evidence defining an optimal needle agitation number, so this randomized comparison addresses a novel but plausible procedural question rather than confirming an established technique.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University Medical Center Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh, Vietnam Recruiting
Study contacts
- Study coordinator: Hieu Q Phan, MD, M.Sc.
- Email: hieu.pq@umc.edu.vn
- Phone: +84907718538
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.