Actively Recruiting
Comparison of Two Needle Agitation Strategies in Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) for Diagnostic Yield
Led by Phan Quang Hieu · Updated on 2026-05-01
180
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
Sponsors
P
Phan Quang Hieu
Lead Sponsor
U
University of Medicine and Pharmacy at Ho Chi Minh City
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Comparison of Two Needle Agitation Strategies in Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) for Diagnostic Yield
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �3E= 18 years
- Enlarged mediastinal or hilar lymph nodes requiring diagnostic evaluation on chest CT (short-axis �3E= 10 mm)
- Clinical indication for EBUS-TBNA
- Ability to provide written informed consent
You will not qualify if you...
- Uncorrected coagulation disorders (platelet count < 100,000/mm�b3; INR > 1.5; or prothrombin time < 50% of control)
- Acute myocardial infarction within 4 weeks or ongoing unstable angina
- Significant upper airway obstruction with �3E= 50% tracheal narrowing
- Hemodynamic instability (persistent hypotension, arrhythmia, or need for vasopressors)
- Respiratory failure not improved by oxygen (SpO2 �3C= 90%)
- Intractable cough preventing bronchoscopy
- Severe allergy to local anesthetics or sedatives used in the procedure
- Refusal or inability to provide informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Medical Center Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh, Vietnam, 700000
Actively Recruiting
Research Team
H
Hieu Q Phan, MD, M.Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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