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The study is aimed o evaluate the diagnostic performance and treatment guidance of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) combined with transbronchial mediastinal cryobiopsy (EBUS-TBMCB) in patients with mediastinal metastases of lung cancer.
A traditional method, endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), will serve as control. Enrolled patients will be randomly assigned to two groups: the experimental group, which will undergo EBUS-guided transbronchial mediastinal cryobiopsy (EBUS-TBMCB) following EBUS-TBNA, and control group, which will undergo EBUS-TBNA alone. Biopsy specimens from both groups will be analyzed by pathologists. All patients will be followed up to confirm the diagnosis and to document any complications. The diagnostic yield for lung cancer and the incidence of procedure-related adverse events will be compared between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBUS-TBNA | No Intervention | Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) will be performed | |
| EBUS-TBNA plus EBUS-TBMCB | Experimental | Following the completion of EBUS-TBNA, EBUS-guided transbronchial mediastinal cryobiopsy (EBUS-TBMCB) will be performed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBUS-TBMCB | Procedure | Endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy will be performed in experimental arm following EBUS-TBNA |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield for lung cancer | For each biopsy modality, diagnostic yield for lung cancer is defined as the percentage of patients with eventually confirmed lung cancer (by histopathology/cytology or long-term follow-up) in whom the initial biopsy using that modality established the diagnosis. | From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy | Diagnostic accuracy was defined as the proportion of patients whose initial test results are consistent with the final diagnosis, based on histopathological/cytological findings and long-term follow-up assessment | From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months |
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Inclusion Criteria:
(1) suspected lung cancer diagnosed by two senior physicians; (2) confirmed lung cancer (requiring mediastinal staging); (3) recurrent lung cancer; 4.Patients must have completed all required preoperative laboratory tests and necessary examinations (e.g., cardiac ultrasound, CTA) to rule out contraindications; 5. Patients are informed and capable of providing written informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanbing Wang | Contact | +86 18885230175 | 18885230175@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Military Medical University | Recruiting | Chongqing | Chongqing Municipality | 400038 | China |
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| Sample size |
The area and diameter of samples obtained by each procedure |
| From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months |
| Suitability for molecular assays | Suitability of NSCLC samples for molecular assays | From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months |
| Duration of bronchoscopic procedure | The duration of each specific step from the start to the end of the biopsy | From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months |
| Incidence of procedure-related adverse events | The ratio of the number of patients who had adverse events caused by the procedures and the number of all patients who have undergone EBUS procedures in each arm | Within 30 days post-biopsy |