Mediastinal LymphadenopathiesCOLLEBERATIONⅢNCT07040670
Diagnostic Yield and Safety of Confocal Laser Endomicroscopy-Assisted Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
A study testing Confocal laser endomicroscopy-assisted endobronchial ultrasound-guided transbronchial needle aspiration and Endobronchial ultrsound-guided Mediastinal cryobiopsy in people with Mediastinal Lymphadenopathies, run by China-Japan Friendship Hospital.
Trial summary
Comparison of the Diagnostic Yield and Safety Between Confocal Laser Endomicroscopy-Assisted Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration and Endobronchial Ultrasound-Guided Transbronchial Mediastinal Cryobiopsy in patients with mediastinal and/or hilar lymphadenopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mediastinal Lymphadenopathies
- What is being tested?
- Confocal laser endomicroscopy-assisted endobronchial ultrasound-guided transbronchial needle aspiration and Endobronchial ultrsound-guided Mediastinal cryobiopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 469 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Jul 2027
- 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
- ≥18 years old
- Patients with at least one mediastinal and/or hilar lymphadenopathy (≥1cm in the short axis) without a known or suspected primary lung cancer, required 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 （3) 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 (4) Unstable angina pectoris, congestive heart failure, severe bronchial asthma
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Diagnostic Yield and Safety Between Confocal Laser Endomicroscopy-Assisted Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration and Endobronchial Ultrasound-Guided Transbronchial Mediastinal Cryobiopsy: a Randomised Controlled Trial
Comparison of the Diagnostic Yield and Safety Between Confocal Laser Endomicroscopy-Assisted Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration and Endobronchial Ultrasound-Guided Transbronchial Mediastinal Cryobiopsy in patients with mediastinal and/or hilar lymphadenopathy.
- Conditions
- Mediastinal Lymphadenopathies
- Being tested
- Confocal laser endomicroscopy-assisted endobronchial ultrasound-guided transbronchial needle aspiration, Endobronchial ultrsound-guided Mediastinal cryobiopsy
- Keywords
- EBUS-TBNA, Confocal laser endomicroscopy, EBUS-TBMC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal laser endomicroscopy-assisted endobronchial ultrasound-guided transbronchial needle aspirationProcedure or surgery
First, use the EBUS needle to create a hole in the airway wall. Then, insert the CLE into the lymph node via this hole and detect the lymph node. When the specific pathological finding is detected by CLE, record the location. Finally, using the needle to perform EBUS-TBNA in the area under EBUS guidance.
Endobronchial ultrsound-guided Mediastinal cryobiopsyProcedure or surgery
Using the cryoprobe to perform EBUS-TBMC three times per person.
| Study group | Role | What they receive |
|---|---|---|
| CLE-assisted EBUS-TBNA | Experimental | Patients in this arm receive CLE-assisted EBUS-TBNA Receives: Procedure: Confocal laser endomicroscopy-assisted endobronchial ultrasound-guided transbronchial needle aspiration |
| EBUS-TBMC | Placebo comparator | Patients in this arm receive EBUS-TBMC Receives: Procedure: Endobronchial ultrsound-guided Mediastinal cryobiopsy |
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 is established based on the consensus definition.
Measured: On day 7 after procedure to obtain the pathological findings.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
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 LymphadenopathiesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 469 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040670
- Sponsor's protocol ID
- 2025-COLLEBERATION-Ⅲ
- Acronym
- COLLEBERATIONⅢ
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zheng Z, Xu L, Wu C, Liao J, Deng M, Tong R, Hou G. Confocal laser endomicroscopy-assisted endobronchial ultrasound-guided needle aspiration in diagnosing mediastinal and/or hilar lymphadenopathy (COLLABORATION-III): protocol for a randomised controlled trial. BMJ Open Respir Res. 2026 Jun 24;13(1):e004263. doi: 10.1136/bmjresp-2026-004263.
PubMed 42342291
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Diagnostic Yield and Safety Between Confocal Laser Endomicroscopy-Assisted Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration and Endobronchial Ultrasound-Guided Transbronchial Mediastinal Cryobiopsy: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07040670
- Acronym / sponsor ID
- COLLEBERATIONⅢ / 2025-COLLEBERATION-Ⅲ
- Conditions
- Mediastinal Lymphadenopathies
- Keywords
- EBUS-TBNA, Confocal laser endomicroscopy, EBUS-TBMC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 469 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 27 Jun 2025 (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.
Comparison of the Diagnostic Yield and Safety Between Confocal Laser Endomicroscopy-Assisted Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration and Endobronchial Ultrasound-Guided Transbronchial Mediastinal Cryobiopsy in patients with mediastinal and/or hilar lymphadenopathy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLE-assisted EBUS-TBNA | Experimental | Procedure: Confocal laser endomicroscopy-assisted endobronchial ultrasound-guided transbronchial needle aspirationPatients in this arm receive CLE-assisted EBUS-TBNA |
| EBUS-TBMC | Placebo comparator | Procedure: Endobronchial ultrsound-guided Mediastinal cryobiopsyPatients in this arm receive EBUS-TBMC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years old
- Patients with at least one mediastinal and/or hilar lymphadenopathy (≥1cm in the short axis) without a known or suspected primary lung cancer, required 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 (2 listed)
- The lesion is a mediastinal cyst or abscess
- The patient is allergic to lidocaine and midazolam （3) 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 (4) Unstable angina pectoris, congestive heart failure, severe bronchial asthma
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 |
|---|---|---|
| Confocal laser endomicroscopy-assisted endobronchial ultrasound-guided transbronchial needle aspirationFirst, use the EBUS needle to create a hole in the airway wall. Then, insert the CLE into the lymph node via this hole and detect the lymph node. When the specific pathological finding is detected by CLE, record the location. Finally, using the needle to perform EBUS-TBNA in the area under EBUS guidance. | Procedure or surgery | CLE-assisted EBUS-TBNA |
| Endobronchial ultrsound-guided Mediastinal cryobiopsyUsing the cryoprobe to perform EBUS-TBMC three times per person. | Procedure or surgery | EBUS-TBMC |
Primary outcome
Diagnostic yield
Time frame: On day 7 after procedure to obtain the pathological findings.
The proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis is established based on the consensus definition.
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 27 Jun 2025.
- Derived from this study: PubMed 42342291Zheng Z, Xu L, Wu C, Liao J, Deng M, Tong R, Hou G. Confocal laser endomicroscopy-assisted endobronchial ultrasound-guided needle aspiration in diagnosing mediastinal and/or hilar lymphadenopathy (COLLABORATION-III): protocol for a randomised controlled trial. BMJ Open Respir Res. 2026 Jun 24;13(1):e004263. doi: 10.1136/bmjresp-2026-004263.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Confocal laser endomicroscopy-assisted endobronchial ultrasound-guided transbronchial needle aspiration and Endobronchial ultrsound-guided Mediastinal cryobiopsy in people with Mediastinal Lymphadenopathies, run by China-Japan Friendship Hospital.
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 2 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: opening soon, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Mingming Deng (+86 18801336854, isdeng1017@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (time frame: On day 7 after procedure to obtain the pathological findings.). 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 NCT07040670, 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 27 Jun 2025.