Lung CancerNCT05628454
Comparison of Three Different Puncture Techniques in EBUS-TBNA
A study testing Endobronchial ultrasound-guided transbronchial needle Slow-pull capillary sampling, Endobronchial ultrasound-guided transbronchial needle aspiration and Endobronchial ultrasound-guided transbronchial needle capillary sampling in people with Lung Cancer and Sarcoidosis, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
The purpose of this study was to compare the accuracy and sensitivity of slow-pull capillary technique, traditional suction aspiration and non negative pressure puncture in the diagnosis of mediastinal and/or hilar lymph node enlargement by ultrasound bronchoscopic lymph node biopsy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer, Sarcoidosis, Tuberculosis
- What is being tested?
- Endobronchial ultrasound-guided transbronchial needle Slow-pull capillary sampling, Endobronchial ultrasound-guided transbronchial needle aspiration and Endobronchial ultrasound-guided transbronchial needle capillary sampling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2022to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80years
- Chest computed tomography showing hilar or mediastinal lymph node enlargement
- No contraindications for bronchoscopy
- Signed informed consent provided by the patient
- Disease needs to be diagnosed through the EBUS-TBNA
Who cannot join
- Severe coagulation dysfunction
- Severe cardiopulmonary dysfunction
- Acute asthma attack or massive haemoptysis
- Poor general condition
- Physical weakness without tolerance for anaesthesia or allergy to narcotic drug
- Disease can be diagnosed by other less invasive methods (such as skin or peripheral superficial lymph node biopsy)
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
The purpose of this study was to compare the accuracy and sensitivity of slow-pull capillary technique, traditional suction aspiration and non negative pressure puncture in the diagnosis of mediastinal and/or hilar lymph node enlargement by ultrasound bronchoscopic lymph node biopsy.
Read the detailed description
EBUS-TBNA has been widely used in the diagnosis of diseases involving lung hilar and mediastinal lymph node enlargement.But different puncture methods are still controversial. Research shows that there was no significant difference in sample adequacy, diagnostic specificity and accuracy between the no negative pressure aspiration and traditional negative pressure aspiration technique.Slow-pull capillary technique is a relatively new operating method of endoscopic ultrasound guided fine needle biopsy in recent years. At present, this technology is widely used in pancreatic space occupying lesions. Compared with the traditional negative pressure aspiration method, our previous retrospective study found that the slow-pull capillary technique can improve the diagnostic accuracy of patients. Therefore, the purpose of this study is to prospectively and randomly compare the advantages and disadvantages of three puncture methods in EBUS-TBNA.
- Conditions
- Lung Cancer, Sarcoidosis, Tuberculosis
- Being tested
- Endobronchial ultrasound-guided transbronchial needle Slow-pull capillary sampling, Endobronchial ultrasound-guided transbronchial needle aspiration, Endobronchial ultrasound-guided transbronchial needle capillary sampling
- Medical subject headings
- Lung Neoplasms, Sarcoidosis, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobronchial ultrasound-guided transbronchial needle Slow-pull capillary samplingProcedure or surgery
Also called Slow-pull capillary technique
The slow-pull capillary technique was performed as follows: after identification and measurement of the target lymph node, a needle was used to puncture the lymph node with the stylet in place.At the same time, the stylet was slowly and continuously pulled to create weak negative pressure.
Endobronchial ultrasound-guided transbronchial needle aspirationProcedure or surgery
Also called Standard suction
The operation steps are the same as above, but the negative pressure device of 10ml syringe is connected behind the puncture needle.
Endobronchial ultrasound-guided transbronchial needle capillary samplingProcedure or surgery
Also called Fine needle sampling without suction
The operation steps are the same as above, but there is no negative pressure device behind the puncture needle
| Study group | Role | What they receive |
|---|---|---|
| EBUS-TBNSP | Experimental | The slow-pull capillary technique was performed as follows: after identification and measurement of the target lymph node, a needle was used to puncture the lymph node with the stylet in place.At the same time, the stylet was slowly and continuously pulled to create weak negative pressure. Receives: Procedure: Endobronchial ultrasound-guided transbronchial needle Slow-pull capillary sampling |
| EBUS-TBNA | Experimental | The operation steps are the same as above, but the negative pressure device of 10ml syringe is connected behind the puncture needle. Receives: Procedure: Endobronchial ultrasound-guided transbronchial needle aspiration |
| EBUS-TBNCS | Experimental | The operation steps are the same as above, but there is no negative pressure device behind the puncture needle Receives: Procedure: Endobronchial ultrasound-guided transbronchial needle capillary sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of three different puncture methods according to pathological diagnosis
The final pathological diagnosis was based on all available cytological and histological samples. In cases with negative pathological results , we continue to follow up the patients for ⩾6months.
Measured: 6 months
Secondary outcomes (3)
Blood contamination of samples
Blood contamination was categorized as follows: low (no or few blood cells influencing the diagnosis), moderate (sample partially obscured by blood cells, but pathological diagnosis possible), and high (large numbers of blood cells, rendering pathological diagnosis difficult)
Measured: 1 week
Bleeding of operation
There are three levels of bleeding:Small amount of bleeding（Ⅰ）: Bleeding can stop spontaneously without continuous suction.Moderate bleeding（Ⅱ）: Continuous suction is required, and epinephrine or ice salt water is used locally to stop bleeding.Massive bleeding（Ⅲ）: Patients who need to be used balloon compression, interventional treatment, or blood transfusion treatment or even died of asphyxia due to bleeding.
Measured: 1 week
Acquisition of tissue core of three different puncture methods according to the judgment of the pathologist
Tissue cores were immersed in formalin solution and subjected to histopathological examination. In the absence of a tissue core, the contents were pressed onto a glass slide, immersed in 96% methanol for ⩾10min and subjected to cytopathological examination.Some methods may only obtain cytological specimens, while others may obtain tissue cores. Tissue cores are better for pathologists to diagnose.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start8 Nov 2022
- Primary completion1 Jun 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanjun Wu, Principal investigator, Beijing Friendship HospitalZhigang Yao, Study director, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628454
- Sponsor's protocol ID
- BFH20221019005
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2022
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu Y, Xu R, Duan X, Deng Y, Yu G, He X, Yao Z. Comparison of three different puncture techniques for endobronchial ultrasound transbronchial needle aspiration: a single-center, prospective, randomized controlled study. BMC Pulm Med. 2025 Sep 30;25(1):437. doi: 10.1186/s12890-025-03917-1.
PubMed 41029266
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Different Puncture Techniques in EBUS-TBNA
- ClinicalTrials.gov ID
- NCT05628454
- Acronym / sponsor ID
- BFH20221019005
- Conditions
- Lung Cancer, Sarcoidosis, Tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 28 Nov 2022 (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 purpose of this study was to compare the accuracy and sensitivity of slow-pull capillary technique, traditional suction aspiration and non negative pressure puncture in the diagnosis of mediastinal and/or hilar lymph node enlargement by ultrasound bronchoscopic lymph node biopsy.
Detailed description
EBUS-TBNA has been widely used in the diagnosis of diseases involving lung hilar and mediastinal lymph node enlargement.But different puncture methods are still controversial. Research shows that there was no significant difference in sample adequacy, diagnostic specificity and accuracy between the no negative pressure aspiration and traditional negative pressure aspiration technique.Slow-pull capillary technique is a relatively new operating method of endoscopic ultrasound guided fine needle biopsy in recent years. At present, this technology is widely used in pancreatic space occupying lesions. Compared with the traditional negative pressure aspiration method, our previous retrospective study found that the slow-pull capillary technique can improve the diagnostic accuracy of patients. Therefore, the purpose of this study is to prospectively and randomly compare the advantages and disadvantages of three puncture methods in EBUS-TBNA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EBUS-TBNSP | Experimental | Procedure: Endobronchial ultrasound-guided transbronchial needle Slow-pull capillary samplingThe slow-pull capillary technique was performed as follows: after identification and measurement of the target lymph node, a needle was used to puncture the lymph node with the stylet in place.At the same time, the stylet was slowly and continuously pulled to create weak negative pressure. |
| EBUS-TBNA | Experimental | Procedure: Endobronchial ultrasound-guided transbronchial needle aspirationThe operation steps are the same as above, but the negative pressure device of 10ml syringe is connected behind the puncture needle. |
| EBUS-TBNCS | Experimental | Procedure: Endobronchial ultrasound-guided transbronchial needle capillary samplingThe operation steps are the same as above, but there is no negative pressure device behind the puncture needle |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80years
- Chest computed tomography showing hilar or mediastinal lymph node enlargement
- No contraindications for bronchoscopy
- Signed informed consent provided by the patient
- Disease needs to be diagnosed through the EBUS-TBNA
Key exclusion criteria (6 listed)
- Severe coagulation dysfunction
- Severe cardiopulmonary dysfunction
- Acute asthma attack or massive haemoptysis
- Poor general condition
- Physical weakness without tolerance for anaesthesia or allergy to narcotic drug
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 |
|---|---|---|
| Endobronchial ultrasound-guided transbronchial needle Slow-pull capillary samplingAlso: Slow-pull capillary techniqueThe slow-pull capillary technique was performed as follows: after identification and measurement of the target lymph node, a needle was used to puncture the lymph node with the stylet in place.At the same time, the stylet was slowly and continuously pulled to create weak negative pressure. | Procedure or surgery | EBUS-TBNSP |
| Endobronchial ultrasound-guided transbronchial needle aspirationAlso: Standard suctionThe operation steps are the same as above, but the negative pressure device of 10ml syringe is connected behind the puncture needle. | Procedure or surgery | EBUS-TBNA |
| Endobronchial ultrasound-guided transbronchial needle capillary samplingAlso: Fine needle sampling without suctionThe operation steps are the same as above, but there is no negative pressure device behind the puncture needle | Procedure or surgery | EBUS-TBNCS |
Primary outcome
Diagnostic accuracy of three different puncture methods according to pathological diagnosis
Time frame: 6 months
The final pathological diagnosis was based on all available cytological and histological samples. In cases with negative pathological results , we continue to follow up the patients for ⩾6months.
3 secondary outcomes
Blood contamination of samples
Time frame: 1 week
Bleeding of operation
Time frame: 1 week
Acquisition of tissue core of three different puncture methods according to the judgment of the pathologist
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Derived from this study: PubMed 41029266Wu Y, Xu R, Duan X, Deng Y, Yu G, He X, Yao Z. Comparison of three different puncture techniques for endobronchial ultrasound transbronchial needle aspiration: a single-center, prospective, randomized controlled study. BMC Pulm Med. 2025 Sep 30;25(1):437. doi: 10.1186/s12890-025-03917-1.
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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. This study is not recruiting at the moment.
Yanjun Wu principal investigator
Beijing Friendship Hospital
Zhigang Yao study director
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endobronchial ultrasound-guided transbronchial needle Slow-pull capillary sampling, Endobronchial ultrasound-guided transbronchial needle aspiration and Endobronchial ultrasound-guided transbronchial needle capillary sampling in people with Lung Cancer and Sarcoidosis, run by Beijing Friendship Hospital at 1 site in China.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 30 Apr 2025. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of three different puncture methods according to pathological diagnosis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05628454, which also lists 1 linked publication.
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 30 Apr 2025.