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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
240
Endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy will be performed in experimental arm following EBUS-TBNA
Third Military Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGDiagnostic 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.
Time frame: From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months
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
Time frame: From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months
Sample size
The area and diameter of samples obtained by each procedure
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: Within 30 days post-biopsy