Diagnostic Yield and Safety of Confocal Laser Endomicroscopy-Assisted Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
NCT ID: NCT07040670
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
469 participants
INTERVENTIONAL
2025-07-01
2027-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
QUADRUPLE
Study Groups
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CLE-assisted EBUS-TBNA
Patients in this arm receive CLE-assisted EBUS-TBNA
Confocal laser endomicroscopy-assisted endobronchial ultrasound-guided transbronchial needle aspiration
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.
EBUS-TBMC
Patients in this arm receive EBUS-TBMC
Endobronchial ultrsound-guided Mediastinal cryobiopsy
Using the cryoprobe to perform EBUS-TBMC three times per person.
Interventions
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Confocal laser endomicroscopy-assisted endobronchial ultrasound-guided transbronchial needle aspiration
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 cryobiopsy
Using the cryoprobe to perform EBUS-TBMC three times per person.
Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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
4. There was no contraindication of puncture and cryobiopsy
5. Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form.
Exclusion Criteria
2. 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
18 Years
ALL
No
Sponsors
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China-Japan Friendship Hospital
OTHER
Responsible Party
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Gang Hou
Deputy Director of the Department of Pulmonary and Critical Care Medicine
Central Contacts
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Other Identifiers
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2025-COLLEBERATION-Ⅲ
Identifier Type: -
Identifier Source: org_study_id
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