Diagnostic Value and Safety of EBUS-TBNA Combined With Medaistinal Cryobiopsy for Mediastinal Metastasis of Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Diagnostic yield for lung cancer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years;
- •Presence of at least one mediastinal lesion (short-axis diameter ≥10 mm) confirmed by thin-slice chest CT;
- •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;
- •Patients are informed and capable of providing written informed consent.
排除标准
- •Presence of severe cardiopulmonary disease, coagulation disorders, massive hemoptysis, poor tolerance to anesthesia, or other contraindications related to bronchoscopy;
- •Intraoperative endobronchial ultrasound exploration of the lesion failed to detect the target lesion despite > 20 minutes of attempts;
- •Lesions identified as abscesses or cysts;
- •Presence of mental illness, severe neurosis, or other conditions that preclude the provision of informed consent;
- •Patients who have participated in other clinical trials within 3 months;
- •Any other conditions considered to be inappropriate to be involved in this trial.
结局指标
主要结局
Diagnostic yield for lung cancer
时间窗: 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.
次要结局
- Diagnostic accuracy(From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months)
- Sample size(From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months)
- Suitability for molecular assays(From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months)
- Duration of bronchoscopic procedure(From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months)
- Incidence of procedure-related adverse events(Within 30 days post-biopsy)
研究者
Ye Fan
Principal investigator
Third Military Medical University