Mediastinal Metastases of Lung Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREEBUS-TBMCB
Endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy will be performed in experimental arm following EBUS-TBNA
Sponsors
Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged ≥18 years; 2. Presence of at least one mediastinal lesion (short-axis diameter ≥10 mm) confirmed by thin-slice chest CT; 3. Patients who have not undergone prior mediastinal biopsy and require further mediastinal biopsy to confirm etiology or pathological subtype, meeting at least one of the following criterias: (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
1. Presence of severe cardiopulmonary disease, coagulation disorders, massive hemoptysis, poor tolerance to anesthesia, or other contraindications related to bronchoscopy; 2. Intraoperative endobronchial ultrasound exploration of the lesion failed to detect the target lesion despite \> 20 minutes of attempts; 3. Lesions identified as abscesses or cysts; 4. Presence of mental illness, severe neurosis, or other conditions that preclude the provision of informed consent; 5. Patients who have participated in other clinical trials within 3 months; 6. Any other conditions considered to be inappropriate to be involved in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield for lung cancer | From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy | From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months | 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 |
| Sample size | From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months | The area and diameter of samples obtained by each procedure |
| Suitability for molecular assays | From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months | Suitability of NSCLC samples for molecular assays |
| Duration of bronchoscopic procedure | From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months | The duration of each specific step from the start to the end of the biopsy |
| Incidence of procedure-related adverse events | Within 30 days post-biopsy | 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 |
Countries
China
Contacts
CONTACTHanbing Wang
Outcome results
None listed