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

NCT07424807 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-05-01

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Medicine and Pharmacy at Ho Chi Minh City

    collaborator OTHER

  • Phan Quang Hieu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-16
Primary Completion
2028-09-30
Completion
2028-12-31

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07424807 on ClinicalTrials.gov