Comparison of Two Needle Agitation Strategies in Endobronchial Ultrasound-guided Transbronchial N… (NCT07424807) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.