Mediastinal LymphadenopathyNCT07424807
Comparison of Two Needle Agitation Strategies in Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) for Diagnostic Yield
A study testing Needle Agitation Strategy During EBUS-TBNA in people with Mediastinal Lymphadenopathy, run by Phan Quang Hieu at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mediastinal Lymphadenopathy
- What is being tested?
- Needle Agitation Strategy During EBUS-TBNA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteVietnam
- Study dates
- 16 Feb 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
University Medical Center Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh, 700000
Hieu Q Phan, MD, M.Sc., +84907718538, hieu.pq@umc.edu.vn
Au T Nguyen, MD, M.Sc., +84853010595, au.nt@umc.edu.vn
About this study
Official title: 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:
Read more
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
Read the 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.
- Conditions
- Mediastinal Lymphadenopathy
- Being tested
- Needle Agitation Strategy During EBUS-TBNA
- Keywords
- EBUS-TBNA, Needle Agitation, Tissue Core Length, Specimen Adequacy, Mediastinal Lymph Nodes, Randomized Controlled Trial, diagnostic yield
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle Agitation Strategy During EBUS-TBNAProcedure or surgery
Also called EBUS-TBNA Needle Agitation, Agitation Number Modification
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Needle Agitation Strategy During EBUS-TBNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 7-14 days after the procedure
Secondary outcomes (1)
Tissue Core Length
Measured length of the tissue core specimen obtained during EBUS-TBNA, recorded in centimeters immediately after specimen collection.
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start16 Feb 2026
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal LymphadenopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two needle agitation strategies during EBUS-TBNA. All other procedural steps will be standardized.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phan Quang Hieu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Phan Quang Hieu, University Medical Center Ho Chi Minh City (UMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424807
- Sponsor's protocol ID
- UMP-EBUS-2026-01
- Other IDs
- IRB-VN01002/IRB00010293
- Status last verified
- Apr 2026
- First submitted
- 14 Feb 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07424807
- Acronym / sponsor ID
- UMP-EBUS-2026-01
- Conditions
- Mediastinal Lymphadenopathy
- Keywords
- EBUS-TBNA, Needle Agitation, Tissue Core Length, Specimen Adequacy, Mediastinal Lymph Nodes, Randomized Controlled Trial, diagnostic yield
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Phan Quang HieuUniversity, hospital or other
- Collaborators
- University of Medicine and Pharmacy at Ho Chi Minh City
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two needle agitation strategies during EBUS-TBNA. All other procedural steps will be standardized.
| Arm | Type | Receives |
|---|---|---|
| 10 to <30 Agitations (Target 20) | Experimental | Procedure: Needle Agitation Strategy During EBUS-TBNAParticipants 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. |
| 30 to 60 Agitations (Target 45-50) | Experimental | Procedure: Needle Agitation Strategy During EBUS-TBNAParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Needle Agitation Strategy During EBUS-TBNAAlso: EBUS-TBNA Needle Agitation, Agitation Number ModificationThe 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. | Procedure or surgery | 10 to <30 Agitations (Target 20), 30 to 60 Agitations (Target 45-50) |
Primary outcome
Diagnostic Yield of EBUS-TBNA
Time frame: Within 7-14 days after the procedure
Proportion of cases in which EBUS-TBNA provides a definitive histopathological diagnosis based on tissue specimens obtained during the procedure.
1 secondary outcome
Tissue Core Length
Time frame: Immediately after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Needle Agitation Strategy During EBUS-TBNA in people with Mediastinal Lymphadenopathy, run by Phan Quang Hieu at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hieu Q Phan, MD, M.Sc. (+84907718538, hieu.pq@umc.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Yield of EBUS-TBNA (time frame: Within 7-14 days after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.