Lymphofollicular Hyperplasia Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Viet Nam
University Medical Center Ho Chi Minh City
RECRUITING
Ho Chi Minh City
Contact Information
Primary
Hieu Q Phan, MD, M.Sc.
hieu.pq@umc.edu.vn
+84907718538
Time Frame
Start Date: 2026-02-16
Estimated Completion Date: 2028-12
Participants
Target number of participants: 180
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Phan Quang Hieu
Collaborators: University of Medicine and Pharmacy at Ho Chi Minh City

This content was sourced from clinicaltrials.gov