Actively Recruiting
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
Led by Phan Quang Hieu · Updated on 2026-05-01
180
Participants Needed
1
Research Sites
13 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
Researchers are evaluating whether the number of needle agitations during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) affects diagnostic accuracy in patients with enlarged mediastinal lymph nodes. This study aims to compare two needle agitation strategies to see if one improves diagnostic yield, tissue sample quality, and safety. The trial addresses the lack of high-level evidence about the best agitation technique and seeks to standardize procedural methods to optimize outcomes while maintaining safety. Participants will be randomly assigned to one of two needle agitation strategies during EBUS-TBNA: a low-range strategy with 10 to fewer than 30 agitations per needle pass (target about 20) or a high-range strategy with 30 to 60 agitations per pass (target about 45 to 50). All other procedural factors, such as needle type, number of passes, suction technique, and specimen handling, will be kept consistent between groups to isolate the effect of agitation number. Participants will undergo EBUS-TBNA as part of their clinical evaluation and have tissue samples measured for core length and assessed for diagnostic adequacy immediately after the procedure. Researchers will monitor for procedure-related complications to assess safety. The main outcome is diagnostic yield within 7 to 14 days after the procedure. The study starts in February 2026 and continues through December 2028, with participants closely followed during and shortly after the procedure.
CONDITIONS
Brief 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 18 years or older
- Enlarged mediastinal or hilar lymph nodes of 10 mm or more on chest CT
- Clinical need for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)
- Ability to provide written informed consent
You will not qualify if you...
- Uncorrected bleeding or clotting disorders (platelet count less than 100,000/mm³; INR greater than 1.5; or prothrombin time less than 50% of control)
- Heart attack within the last 4 weeks or unstable chest pain
- Significant upper airway blockage reducing tracheal diameter by 50% or more
- Unstable blood pressure or heart rhythm requiring medication support
- Respiratory failure not improved by oxygen therapy (oxygen saturation 90% or below despite oxygen)
- Severe cough preventing bronchoscopy
- Severe allergy to local anesthetics or sedatives used in the procedure
- Unable or unwilling to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) with one of two needle agitation strategies to collect samples from enlarged mediastinal lymph nodes.
1 procedure visit (in-person)
Duration - 7 to 14 days
Participants are monitored for diagnostic results and procedural safety following the EBUS-TBNA procedure.
1 follow-up visit (in-person)
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.
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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