Lymphadenopathy HilarNCT06262620
The Comparison of EBUS-TBNA, TBMC Via a Tunnel, and TBFB Via a Tunnel in Diagnosing Mediastinal Lymphadenopathy.
A study testing EBUS-TBNA, EBUS-TBMC via a tunnel and EBUS-TBFB via a tunnel in people with Lymphadenopathy Hilar and Lymphadenopathy Mediastinal, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
The goal of this prospective, multi-centre, randomised controlled clinical study is to compare the diagnostic yield and safety of the three biopsy techniques (EBUS-TBNA, EBUS-TBMC via a tunnel, and EBUS-TBFB via a tunnel) in mediastinal/hilar lymph node biopsies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphadenopathy Hilar, Lymphadenopathy Mediastinal
- What is being tested?
- EBUS-TBNA, EBUS-TBMC via a tunnel and EBUS-TBFB via a tunnel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 18 Feb 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- At least 1 hilar/mediastinal lesion (short axis ≥ 1 cm) requiring diagnostic bronchoscopy procedure;
- Patients who can understand the purpose of the trial, participate voluntarily and sign an informed consent form.
Who cannot join
- The lesion is a mediastinal cyst or abscess;
- Combined severe cardiopulmonary diseases, coagulation disorders, poor tolerance to anaesthesia, combined psychiatric disorders or severe neurosis and other relevant contraindications to bronchoscopy;
- EBUS assessment reveals that the lesion is rich in blood flow or adjacent to a large vessel, etc. Consider biopsy to be high risk and inappropriate for continuation of biopsy;
- EBUS did not detect lesions in the hilum and/or mediastinum;
- Those who, in the judgement of the investigator, have poor patient compliance and are unable to complete the study as required due to mental disorders, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Mingming Deng, MD, 18801336854, isdeng1017@163.com
About this study
Official title: The Comparison of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration, Mediastinal Cryobiopsy Via a Tunnel, and Forceps Biopsy Via a Tunnel in Diagnosing Mediastinal Lymphadenopathy: a Multicenter Randomised Controlled Trial.
The goal of this prospective, multi-centre, randomised controlled clinical study is to compare the diagnostic yield and safety of the three biopsy techniques (EBUS-TBNA, EBUS-TBMC via a tunnel, and EBUS-TBFB via a tunnel) in mediastinal/hilar lymph node biopsies.
Participants will divided into EBUS-TBNA group, EBUS-TBMC via a tunnel group, and EBUS-TBFB via a tunnel group at a 1:1:1 ratio by using central, computerized random sequence, and then undertake EBUS-TBNA, EBUS-TBMC via a tunnel, or EBUS-TBFB according to the group.
Researchers will compare the diagnostic yield and incidence of adverse events of the three biopsy techniques.
- Conditions
- Lymphadenopathy Hilar, Lymphadenopathy Mediastinal
- Being tested
- EBUS-TBNA, EBUS-TBMC via a tunnel, EBUS-TBFB via a tunnel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS-TBNAProcedure or surgery
Also called Endobronchial ultrasound-guided transbronchial needle aspiration.
A 22G biopsy needle was insert into the lesion through tracheal-bronchial wall under real-time EBUS guided by bronchoscopist. Needle punctures were performed by using the jabbing method. Once it is confirmed that the puncture needle is within the target lesion, the puncture needle is moved back and forth while suction (An empty 50 ml syringe was connected to the port at the end of the puncture needle and aspirated to 20 ml maintained for 20 seconds.) is applied. Each lymph node was operated 5 times.
EBUS-TBMC via a tunnelProcedure or surgery
Also called endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnel.
First a tunnel between airway wall and mediastinal and/or hilar lesion was made by a puncture dilation catheter (BroncTruTM AK-91-55, Bronchus Inc. Hangzhou, China). The 1.1mm cryoprobe (Erbe 20402-401, ERBE, Tübingen, Germany) entered the target lymph node through the tunnel under direct monitoring of EBUS, and the distance between the tip of the cryoprobe and the border of target lymph node was measured using EBUS. After confirming that the distance was >5 mm, the probe was cooled with liquid carbon dioxide for 5-9 seconds. Then retracted with the bronchoscope and the frozen biopsy tissue. Samples were retrieved by thawing in saline and then fixed in formalin. The same lymph node was operated for 3 times.
EBUS-TBFB via a tunnelProcedure or surgery
Also called endobronchial ultrasound-guided transbronchial forceps biopsy
Firstly, a tunnel to reach the lymph node is established by making use of a puncture dilation catheter, and a 1.5mm biopsy forceps is pushed into the lymph node through the working channel of the ultrasound bronchoscope. After entering the lymph node, the biopsy forceps were opened proximally to the lymph node, the biopsy forceps were advanced, and then the biopsy forceps were closed distally to the lymph node for each specimen. Each lymph node was operated 5 times.
| Study group | Role | What they receive |
|---|---|---|
| EBUS-transbronchial needle aspiration | Experimental | Participants would undertake EBUS-transbronchial needle aspiration. Receives: Procedure: EBUS-TBNA |
| EBUS-transbronchial mediastinal cryobiopsy via a tunnel | Experimental | Participants would undertake EBUS-transbronchial mediastinal cryobiopsy via a tunnel. Receives: Procedure: EBUS-TBMC via a tunnel |
| EBUS-transbronchial forceps biopsy via a tunnel | Experimental | Participants would undertake EBUS-transbronchial forceps biopsy via a tunnel. Receives: Procedure: EBUS-TBFB via a tunnel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dignostic yield of EBUS-TBNA, EBUS-TBMC via a tunnel, and EBUS-TBFB
The proportion of participants in whom the biopsy led to a definitive diagnosis.
Measured: 7 days after the biopsy
Incidence rate of adverse events
Symptoms and signs
Measured: 7 days after the biopsy
the adequacy of sample acquisition
Samples resulting in a specific diagnosis or samples with the presence of lymphpcytes were considered as adequate.
Measured: 7 days after the biopsy
Secondary outcomes (1)
the adequacy of sample acquisition
Samples resulting in a specific diagnosis or samples with the presence of lymphpcytes were considered as adequate.
Measured: 7 days after the biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Mar 2024
- Primary completion18 Feb 2026 (estimated)
- Study completion18 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lymphadenopathy HilarStudies of the same condition, open and under way.
- More trials run by China-Japan 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 552 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
- Investigators
- Gang Hou, MD, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262620
- Sponsor's protocol ID
- 2022-NHLHCRF-LX-01-0201-06
- Status last verified
- Aug 2024
- First submitted
- 1 Feb 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Deng M, Zheng Z, Zhang X, Xia Y, Tang F, Yang Z, Zhong C, Tong R, Zhou G, Li X, Zhao L, Dai H, Hou G. EBUS-guided transbronchial mediastinal cryobiopsy for diagnosing non-metastatic lymphadenopathy: A randomized controlled trial. Med. 2026 Feb 13;7(2):100962. doi: 10.1016/j.medj.2025.100962. Epub 2026 Jan 26.
PubMed 41592566Deng MM, Yang Z, Zhong C, Zheng Z, Tong R, Zhou G, Li X, Zhao L, Herth FJF, Hou G. Comparison of diagnostic yield and safety of three endobronchial ultrasound-guided transbronchial biopsy techniques in diagnosing patients with mediastinal/hilar lymphadenopathy: a protocol of multicentre randomised trial in China. BMJ Open. 2025 Sep 23;15(9):e096871. doi: 10.1136/bmjopen-2024-096871.
PubMed 40987727
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration, Mediastinal Cryobiopsy Via a Tunnel, and Forceps Biopsy Via a Tunnel in Diagnosing Mediastinal Lymphadenopathy: a Multicenter Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT06262620
- Acronym / sponsor ID
- 2022-NHLHCRF-LX-01-0201-06
- Conditions
- Lymphadenopathy Hilar, Lymphadenopathy Mediastinal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 552 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 18 Feb 2026 (estimated)
- Study completion
- 18 Feb 2026 (estimated)
- First posted
- 16 Feb 2024 (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 prospective, multi-centre, randomised controlled clinical study is to compare the diagnostic yield and safety of the three biopsy techniques (EBUS-TBNA, EBUS-TBMC via a tunnel, and EBUS-TBFB via a tunnel) in mediastinal/hilar lymph node biopsies.
Participants will divided into EBUS-TBNA group, EBUS-TBMC via a tunnel group, and EBUS-TBFB via a tunnel group at a 1:1:1 ratio by using central, computerized random sequence, and then undertake EBUS-TBNA, EBUS-TBMC via a tunnel, or EBUS-TBFB according to the group.
Researchers will compare the diagnostic yield and incidence of adverse events of the three biopsy techniques.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EBUS-transbronchial needle aspiration | Experimental | Procedure: EBUS-TBNAParticipants would undertake EBUS-transbronchial needle aspiration. |
| EBUS-transbronchial mediastinal cryobiopsy via a tunnel | Experimental | Procedure: EBUS-TBMC via a tunnelParticipants would undertake EBUS-transbronchial mediastinal cryobiopsy via a tunnel. |
| EBUS-transbronchial forceps biopsy via a tunnel | Experimental | Procedure: EBUS-TBFB via a tunnelParticipants would undertake EBUS-transbronchial forceps biopsy via a tunnel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- At least 1 hilar/mediastinal lesion (short axis ≥ 1 cm) requiring diagnostic bronchoscopy procedure;
- Patients who can understand the purpose of the trial, participate voluntarily and sign an informed consent form.
Key exclusion criteria (5 listed)
- The lesion is a mediastinal cyst or abscess;
- Combined severe cardiopulmonary diseases, coagulation disorders, poor tolerance to anaesthesia, combined psychiatric disorders or severe neurosis and other relevant contraindications to bronchoscopy;
- EBUS assessment reveals that the lesion is rich in blood flow or adjacent to a large vessel, etc. Consider biopsy to be high risk and inappropriate for continuation of biopsy;
- EBUS did not detect lesions in the hilum and/or mediastinum;
- Those who, in the judgement of the investigator, have poor patient compliance and are unable to complete the study as required due to mental disorders, etc.
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 |
|---|---|---|
| EBUS-TBNAAlso: Endobronchial ultrasound-guided transbronchial needle aspiration.A 22G biopsy needle was insert into the lesion through tracheal-bronchial wall under real-time EBUS guided by bronchoscopist. Needle punctures were performed by using the jabbing method. Once it is confirmed that the puncture needle is within the target lesion, the puncture needle is moved back and forth while suction (An empty 50 ml syringe was connected to the port at the end of the puncture needle and aspirated to 20 ml maintained for 20 seconds.) is applied. Each lymph node was operated 5 times. | Procedure or surgery | EBUS-transbronchial needle aspiration |
| EBUS-TBMC via a tunnelAlso: endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnel.First a tunnel between airway wall and mediastinal and/or hilar lesion was made by a puncture dilation catheter (BroncTruTM AK-91-55, Bronchus Inc. Hangzhou, China). The 1.1mm cryoprobe (Erbe 20402-401, ERBE, Tübingen, Germany) entered the target lymph node through the tunnel under direct monitoring of EBUS, and the distance between the tip of the cryoprobe and the border of target lymph node was measured using EBUS. After confirming that the distance was >5 mm, the probe was cooled with liquid carbon dioxide for 5-9 seconds. Then retracted with the bronchoscope and the frozen biopsy tissue. Samples were retrieved by thawing in saline and then fixed in formalin. The same lymph node was operated for 3 times. | Procedure or surgery | EBUS-transbronchial mediastinal cryobiopsy via a tunnel |
| EBUS-TBFB via a tunnelAlso: endobronchial ultrasound-guided transbronchial forceps biopsyFirstly, a tunnel to reach the lymph node is established by making use of a puncture dilation catheter, and a 1.5mm biopsy forceps is pushed into the lymph node through the working channel of the ultrasound bronchoscope. After entering the lymph node, the biopsy forceps were opened proximally to the lymph node, the biopsy forceps were advanced, and then the biopsy forceps were closed distally to the lymph node for each specimen. Each lymph node was operated 5 times. | Procedure or surgery | EBUS-transbronchial forceps biopsy via a tunnel |
Primary outcome
Dignostic yield of EBUS-TBNA, EBUS-TBMC via a tunnel, and EBUS-TBFB
Time frame: 7 days after the biopsy
The proportion of participants in whom the biopsy led to a definitive diagnosis.
Incidence rate of adverse events
Time frame: 7 days after the biopsy
Symptoms and signs
the adequacy of sample acquisition
Time frame: 7 days after the biopsy
Samples resulting in a specific diagnosis or samples with the presence of lymphpcytes were considered as adequate.
1 secondary outcome
the adequacy of sample acquisition
Time frame: 7 days after the biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Derived from this study: PubMed 41592566Deng M, Zheng Z, Zhang X, Xia Y, Tang F, Yang Z, Zhong C, Tong R, Zhou G, Li X, Zhao L, Dai H, Hou G. EBUS-guided transbronchial mediastinal cryobiopsy for diagnosing non-metastatic lymphadenopathy: A randomized controlled trial. Med. 2026 Feb 13;7(2):100962. doi: 10.1016/j.medj.2025.100962. Epub 2026 Jan 26.
- Derived from this study: PubMed 40987727Deng MM, Yang Z, Zhong C, Zheng Z, Tong R, Zhou G, Li X, Zhao L, Herth FJF, Hou G. Comparison of diagnostic yield and safety of three endobronchial ultrasound-guided transbronchial biopsy techniques in diagnosing patients with mediastinal/hilar lymphadenopathy: a protocol of multicentre randomised trial in China. BMJ Open. 2025 Sep 23;15(9):e096871. doi: 10.1136/bmjopen-2024-096871.
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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.
Gang Hou, MD principal investigator
China-Japan 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 EBUS-TBNA, EBUS-TBMC via a tunnel and EBUS-TBFB via a tunnel in people with Lymphadenopathy Hilar and Lymphadenopathy Mediastinal, run by China-Japan 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang Hou, MD (010-84205729, hougangcmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dignostic yield of EBUS-TBNA, EBUS-TBMC via a tunnel, and EBUS-TBFB (time frame: 7 days after the biopsy). The study lists 3 primary outcomes in all. 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 NCT06262620, which also lists 2 linked publications.
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 27 Aug 2024.