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

NCT07424807 | Recruiting

• 2 other identifiers: UMP-EBUS-2026-01IRB-VN01002/IRB00010293
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Mediastinal Lymphadenopathy

Keywords

EBUS-TBNA; Needle Agitation; Tissue Core Length; Specimen Adequacy; Mediastinal Lymph Nodes; Randomized Controlled Trial; diagnostic yield

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Tissue Core Length

  Immediately after the procedure

Other Outcomes (1)

• Procedure-Related Complication Rate

  Within 30 days after the procedure

Study Arms (2)

10 to <30 Agitations (Target 20)

EXPERIMENTAL

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

30 to 60 Agitations (Target 45-50)

EXPERIMENTAL

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

Interventions

Needle Agitation Strategy During EBUS-TBNA PROCEDURE

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.

Also known as: EBUS-TBNA Needle Agitation, Agitation Number Modification

10 to <30 Agitations (Target 20); 30 to 60 Agitations (Target 45-50)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Phan Quang Hieu: lead
• University of Medicine and Pharmacy at Ho Chi Minh City: collaborator

Study Sites (1)

University Medical Center Ho Chi Minh City

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

RECRUITING

Central Study Contacts

Hieu Q Phan, MD, M.Sc.

CONTACT

+84907718538; hieu.pq@umc.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The pathologists evaluating the tissue specimens will be blinded to group allocation. Participants will not be informed of the assigned needle agitation strategy.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to one of two needle agitation strategies during EBUS-TBNA. All other procedural steps will be standardized.

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: February 20, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months after publication of the primary results and will remain available for 5 years following publication.
• 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.

Locations

VN (1)