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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLE-assisted EBUS-TBNA | Experimental | Patients in this arm receive CLE-assisted EBUS-TBNA |
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| EBUS-TBMC | Placebo Comparator | Patients in this arm receive EBUS-TBMC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Confocal laser endomicroscopy-assisted endobronchial ultrasound-guided transbronchial needle aspiration | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | On day 7 after procedure to obtain the pathological findings. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingming Deng | Contact | +86 18801336854 | isdeng1017@163.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42342291 | Derived | 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. |
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| Endobronchial ultrsound-guided Mediastinal cryobiopsy | Procedure | Using the cryoprobe to perform EBUS-TBMC three times per person. |
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