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

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

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

Study Overview

• Status: Recruiting
• Conditions: Mediastinal Lymphadenopathy
• Intervention / Treatment: Procedure: Needle Agitation Strategy During EBUS-TBNA

Detailed Description

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has become the standard minimally invasive modality for sampling mediastinal lymph nodes in patients with suspected thoracic malignancies and benign lymphadenopathies. Despite its widespread adoption and high overall diagnostic performance, variability in procedural techniques may contribute to heterogeneity in specimen quality and diagnostic yield.

Among procedural factors, the number of needle agitations performed during each needle pass represents a modifiable technical variable that may influence tissue acquisition. Increased needle agitation may theoretically enhance tissue yield and core length by promoting mechanical dissection of nodal tissue; however, excessive agitation may also increase blood contamination, reduce sample interpretability, or elevate procedural trauma risk. Conversely, fewer agitations may limit tissue disruption but potentially result in inadequate sampling. Currently, there is no high-level evidence establishing an optimal agitation strategy, and operator-dependent variability remains common in clinical practice.

This randomized, single-blind controlled trial is designed to compare two predefined needle agitation strategies during EBUS-TBNA. By standardizing all other procedural variables, the study aims to isolate the effect of agitation number on diagnostic performance. Objective procedural metrics, including measured tissue core length and specimen adequacy, will be systematically assessed to provide quantitative evaluation of sample quality. Procedural safety outcomes will also be monitored to evaluate whether differences in agitation strategy influence complication rates.

The results of this trial are expected to provide evidence-based data to support technical standardization of EBUS-TBNA and to inform procedural guidelines aimed at optimizing diagnostic efficiency while maintaining safety.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hieu Q Phan, MD, M.Sc.; Phone Number: +84907718538; Email: hieu.pq@umc.edu.vn

Study Locations

• Vietnam
  • Ho Chi Minh
    • Ho Chi Minh City, Ho Chi Minh, Vietnam, 700000
      • Recruiting
      • University Medical Center Ho Chi Minh City
      • Contact: Hieu Q Phan, MD, M.Sc.; Phone Number: +84907718538; Email: hieu.pq@umc.edu.vn
      • Contact: Au T Nguyen, MD, M.Sc.; Phone Number: +84853010595; Email: au.nt@umc.edu.vn
      • Principal Investigator: Hieu Q Phan, MD, M.Sc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10 to <30 Agitations (Target 20); Participants will undergo endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) using a low-range needle agitation strategy: 10 to fewer than 30 needle agitations per needle pass, with a target of approximately 20 agitations. All other procedural parameters, including needle type, number of passes, suction technique, and specimen handling, will be standardized.	Procedure: Needle Agitation Strategy During EBUS-TBNA; The intervention consists of modifying the number of needle agitations performed during each needle pass in endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). Participants are randomized to one of two predefined agitation strategies: a low-range strategy (10 to fewer than 30 agitations per pass, target approximately 20) or a high-range strategy (30 to 60 agitations per pass, target approximately 45 to 50). All other procedural variables, including needle type, number of passes, suction technique, and specimen handling, are standardized.; Other Names: EBUS-TBNA Needle Agitation; Agitation Number Modification
Experimental: 30 to 60 Agitations (Target 45-50); Participants will undergo endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) using a high-range needle agitation strategy: 30 to 60 needle agitations per needle pass, with a target of approximately 45 to 50 agitations. All other procedural parameters, including needle type, number of passes, suction technique, and specimen handling, will be standardized.	Procedure: Needle Agitation Strategy During EBUS-TBNA; The intervention consists of modifying the number of needle agitations performed during each needle pass in endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). Participants are randomized to one of two predefined agitation strategies: a low-range strategy (10 to fewer than 30 agitations per pass, target approximately 20) or a high-range strategy (30 to 60 agitations per pass, target approximately 45 to 50). All other procedural variables, including needle type, number of passes, suction technique, and specimen handling, are standardized.; Other Names: EBUS-TBNA Needle Agitation; Agitation Number Modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Yield of EBUS-TBNA	Proportion of cases in which EBUS-TBNA provides a definitive histopathological diagnosis based on tissue specimens obtained during the procedure.	Within 7-14 days after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue Core Length	Measured length of the tissue core specimen obtained during EBUS-TBNA, recorded in centimeters immediately after specimen collection.	Immediately after the procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure-Related Complication Rate	Incidence of procedure-related complications, including bleeding, infection, pneumothorax, or other adverse events associated with EBUS-TBNA.	Within 30 days after the procedure

Collaborators and Investigators

• Sponsor: Phan Quang Hieu
• Collaborators: University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 14, 2026
• First Submitted That Met QC Criteria: February 14, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; EBUS-TBNA; diagnostic yield; Specimen Adequacy; Needle Agitation; Tissue Core Length; Mediastinal Lymph Nodes
• Other Study ID Numbers: UMP-EBUS-2026-01; IRB-VN01002/IRB00010293 (Other Grant/Funding Number: University of Medicine and Pharmacy at Ho Chi Minh City)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the results reported in the publication, including demographic characteristics, procedural variables, primary and secondary outcome data, and safety outcomes.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the primary results and will remain available for 5 years following publication.
• IPD Sharing Access Criteria: Access will be granted upon reasonable request to researchers who provide a methodologically sound proposal. Requests will be reviewed by the principal investigator and, where required, the institutional review board. De-identified data will be shared after execution of a data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No