Mediastinal LymphadenopathyNCT05803239
Study on Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy Via a Tunnel in the Diagnosis of Mediastinal Lymphadenopathy
A study testing EBUS-TBNA and EBUS-TBMC via a tunnel in people with Mediastinal Lymphadenopathy, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to clear the diagnostic yield and safety of endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (TBMC) via a tunnel. The main questions it aims to answer are: Does EBUS-TBMC via a tunnel have a superior diagnostic yield to EBUS-transbronchial needle aspiration… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mediastinal Lymphadenopathy
- What is being tested?
- EBUS-TBNA and EBUS-TBMC via a tunnel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2023to 18 Mar 2025
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with at least one mediastinal and/or hilar lymphadenopathy (≥1cm in the short axis) in the absence of a known or suspected primary lung cancer, requiring diagnostic bronchoscopy.
- The selected patients should complete the routine examination of EBUS-TBNA/EBUS-TBMC via a tunnel before operation, such as blood routine examination, coagulation function, electrocardiogram, chest CT, etc.
- There was no contraindication of puncture and cryobiopsy.
- Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form.
Who cannot join
- The lesion is a mediastinal cyst or abscess.
- The patient is allergic to lidocaine and midazolam.
- The site to be biopsied has a high risk of bleeding detected by Doppler and/or contrast CT such as bronchial artery penetration or suspected lung metastasis of renal cancer.
- Unstable angina pectoris, congestive heart failure, severe bronchial asthma
- The patient did not agree to participate in this study
- Participation in other studies within three months without withdrawal or termination will affect the observation of this study
- The researcher believes that there is any person who is not suitable for the selection
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: The Diagnostic Yield and Safety of Endobronchial Ultrasound-guided Mediastinal Cryobiopsy Via a Tunnel in Mediastinal Lymphadenopathy
The goal of this clinical trial is to clear the diagnostic yield and safety of endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (TBMC) via a tunnel. The main questions it aims to answer are:
Does EBUS-TBMC via a tunnel have a superior diagnostic yield to EBUS-transbronchial needle aspiration (TBNA)? When EBUS-TBMC via a tunnel could be performed as a first-line diagnostic tool in patients with mediastinal and/or hilar lymphadenopathy?
Read more
Researchers will compare EBUS-TBMC via a tunnel to EBUS-TBNA to see if EBUS-TBMC via a tunnel has a superior of diagnostic yield with a well-tolerance.
Participants will:
Recieve EBUS-TBMC via a tunnel and EBUS-TBNA in a predefined sequence. Recieve chest CT examination and follow-up for 7 days after procedure.
- Conditions
- Mediastinal Lymphadenopathy
- Being tested
- EBUS-TBNA, EBUS-TBMC 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
Participants with lymphadenopathy would receive EBUS-TBNA attempts to conduct diagnoses.
EBUS-TBMC via a tunnelProcedure or surgery
Participants with lymphadenopathy would receive EBUS-TBMC via a tunnel attempts to conduct diagnoses.
| Study group | Role | What they receive |
|---|---|---|
| EBUS-TBMC via a tunnel first group | Experimental | After completing the routine bronchoscopy examination, under the EBUS guidance, combined with the results of chest CT to determine the location of puncture. Then, a disposable puncture dilation catheter (BroncTru AK-91-55; Broncus Inc., Hangzhou, China) was inserted through the working channel of the ultrasound bronchoscope and built a tunnel between the airway wall and targeted lymph node. The 1.1-mm cryoprobe (Erbe 20402-401; ERBE, Tübingen, Germany) was inserted into the target lymph node through the tunnel under direct EBUS monitoring, and the distance between the tip of the cryoprobe and the border of the 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 and freezing 3 times to obtain 3 pieces of sample. At the end of TBMC via a tunnel, EBUS-TBNA is performed in the same lymph node, and the tissue is aspirated repeatedly for 5 strokes (one stroke is 30 round trips). Receives: Procedure: EBUS-TBNA; Procedure: EBUS-TBMC via a tunnel |
| EBUS-TBNA first group | Experimental | Completion of routine bronchoscopy, determination of the puncture position under EBUS guidance, combined with the results of chest CT, and application of the EBUS-TBNA needle to repeatedly aspirate the tissue for 5 strokes (one stroke is 30 round trips ). At the end of the puncture, EBUS-TBMC via a tunnel was then performed with a freezing time of 5-9 seconds (1.1-mm cryoprobe), and frozen 3 times to obtain 3 pieces of samples. Receives: Procedure: EBUS-TBNA; Procedure: EBUS-TBMC via a tunnel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
The proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis was established. All the final diagnosis in this trial were established by the treating clinician and verified by an independent diagnosis verification panel which included three pulmonary and critical care medicine physicians, one radiologist, and one pathologist.
Measured: 6 months after the biopsy
Secondary outcomes (4)
Diagnostic sensitivity
The proportion of individuals who truly had the disease and tested positive.
Measured: 6 months after biopsy.
Incidence rate of adverse events
Symptoms and signs
Measured: 7 days after the biopsy
Size of specimen
measurement
Measured: during the procedure
Specimen quality
questionnaire
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start18 Feb 2023
- Primary completion18 Mar 2025
- Study completion18 Mar 2025
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 Mediastinal LymphadenopathyStudies 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
- None (open label)
- Enrolment
- 156 participants (actual)
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
- NCT05803239
- Sponsor's protocol ID
- 2022-NHLHCRF-LX-01-0201-03
- Status last verified
- May 2025
- First submitted
- 14 Mar 2023
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 41592566
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Yield and Safety of Endobronchial Ultrasound-guided Mediastinal Cryobiopsy Via a Tunnel in Mediastinal Lymphadenopathy
- ClinicalTrials.gov ID
- NCT05803239
- Acronym / sponsor ID
- 2022-NHLHCRF-LX-01-0201-03
- Conditions
- Mediastinal Lymphadenopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 18 Feb 2023 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 7 Apr 2023 (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 clear the diagnostic yield and safety of endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (TBMC) via a tunnel. The main questions it aims to answer are:
Does EBUS-TBMC via a tunnel have a superior diagnostic yield to EBUS-transbronchial needle aspiration (TBNA)? When EBUS-TBMC via a tunnel could be performed as a first-line diagnostic tool in patients with mediastinal and/or hilar lymphadenopathy?
Researchers will compare EBUS-TBMC via a tunnel to EBUS-TBNA to see if EBUS-TBMC via a tunnel has a superior of diagnostic yield with a well-tolerance.
Participants will:
Recieve EBUS-TBMC via a tunnel and EBUS-TBNA in a predefined sequence. Recieve chest CT examination and follow-up for 7 days after procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBUS-TBMC via a tunnel first group | Experimental | Procedure: EBUS-TBNA, Procedure: EBUS-TBMC via a tunnelAfter completing the routine bronchoscopy examination, under the EBUS guidance, combined with the results of chest CT to determine the location of puncture. Then, a disposable puncture dilation catheter (BroncTru AK-91-55; Broncus Inc., Hangzhou, China) was inserted through the working channel of the ultrasound bronchoscope and built a tunnel between the airway wall and targeted lymph node. The 1.1-mm cryoprobe (Erbe 20402-401; ERBE, Tübingen, Germany) was inserted into the target lymph node through the tunnel under direct EBUS monitoring, and the distance between the tip of the cryoprobe and the border of the 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 and freezing 3 times to obtain 3 pieces of sample. At the end of TBMC via a tunnel, EBUS-TBNA is performed in the same lymph node, and the tissue is aspirated repeatedly for 5 strokes (one stroke is 30 round trips). |
| EBUS-TBNA first group | Experimental | Procedure: EBUS-TBNA, Procedure: EBUS-TBMC via a tunnelCompletion of routine bronchoscopy, determination of the puncture position under EBUS guidance, combined with the results of chest CT, and application of the EBUS-TBNA needle to repeatedly aspirate the tissue for 5 strokes (one stroke is 30 round trips ). At the end of the puncture, EBUS-TBMC via a tunnel was then performed with a freezing time of 5-9 seconds (1.1-mm cryoprobe), and frozen 3 times to obtain 3 pieces of samples. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with at least one mediastinal and/or hilar lymphadenopathy (≥1cm in the short axis) in the absence of a known or suspected primary lung cancer, requiring diagnostic bronchoscopy.
- The selected patients should complete the routine examination of EBUS-TBNA/EBUS-TBMC via a tunnel before operation, such as blood routine examination, coagulation function, electrocardiogram, chest CT, etc.
- There was no contraindication of puncture and cryobiopsy.
- Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form.
Key exclusion criteria (7 listed)
- The lesion is a mediastinal cyst or abscess.
- The patient is allergic to lidocaine and midazolam.
- The site to be biopsied has a high risk of bleeding detected by Doppler and/or contrast CT such as bronchial artery penetration or suspected lung metastasis of renal cancer.
- Unstable angina pectoris, congestive heart failure, severe bronchial asthma
- The patient did not agree to participate in this study
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-TBNAParticipants with lymphadenopathy would receive EBUS-TBNA attempts to conduct diagnoses. | Procedure or surgery | EBUS-TBMC via a tunnel first group, EBUS-TBNA first group |
| EBUS-TBMC via a tunnelParticipants with lymphadenopathy would receive EBUS-TBMC via a tunnel attempts to conduct diagnoses. | Procedure or surgery | EBUS-TBMC via a tunnel first group, EBUS-TBNA first group |
Primary outcome
Diagnostic yield
Time frame: 6 months after the biopsy
The proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis was established. All the final diagnosis in this trial were established by the treating clinician and verified by an independent diagnosis verification panel which included three pulmonary and critical care medicine physicians, one radiologist, and one pathologist.
4 secondary outcomes
Diagnostic sensitivity
Time frame: 6 months after biopsy.
Incidence rate of adverse events
Time frame: 7 days after the biopsy
Size of specimen
Time frame: during the procedure
Specimen quality
Time frame: during the procedure
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 20 Jul 2025.
- 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.
- Individual participant dataSharing planned: No
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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 and EBUS-TBMC via a tunnel in people with Mediastinal Lymphadenopathy, 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 4 inclusion and 7 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 20 Jul 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 yield (time frame: 6 months after the biopsy). 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 NCT05803239, 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 20 Jul 2025.