The Effectiveness and Safety of Ultrasound Elastography Guided Pleural Biopsy in the Differential Diagnosis of Benign and Malignant Pleural Effusion
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 592
- 试验地点
- 9
- 主要终点
- Efficacy of ultrasound elastography guided pleural biopsy versus traditional ultrasound-guided pleural biopsy for diagnosis of pleural effusion.
研究概览
简要总结
The goal of this clinical trial is to evaluate the diagnostic effcacy and safety of ultrasound elastography guided pleural biopsy in the differential diagnosis of benign and malignant pleural effusion. The main question it aims to answer are: the effectiveness and safety of ultrasound elastography guided pleural biopsy in the differential diagnosis of benign and malignant pleural effusion.
Participants will undergo ultrasound elastography guided pleural biopsy or traditional ultrasound-guided pleural biopsy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unexplained pleural effusion (patients with pleural effusion with negative aspiration)
- •Sign the informed consent form
- •The patient must have chest CT, biochemical examination of pleural fluid, cytological examination of pleural fluid and other data before operation
排除标准
- •The cytological examination of pleural fluid indicates "highly suspicious" patients (unless the cytological examination results of patients are inconsistent with clinical manifestations and CT examination). The pleural fluid cytology proved to be malignant. Patients with severe pleural adhesion who cannot undergo medical thoracoscopic examination will not be randomly selected, and elastic ultrasound-guided biopsy can be performed after informed consent, as a subgroup of population analysis. Those who cannot tolerate closed pleural biopsy due to severe cardiopulmonary dysfunction and poor general condition Coagulation dysfunction. Leakage. The age is less than 18 years old.
- •The pleural fluid cytology proved to be malignant.
- •Patients with severe pleural adhesion who cannot undergo medical thoracoscopic examination will not be randomly selected, and elastic ultrasound-guided biopsy can be performed after informed consent, as a subgroup of population analysis.
- •Those who cannot tolerate closed pleural biopsy due to severe cardiopulmonary dysfunction and poor general condition
- •Coagulation dysfunction.
- •The age is less than 18 years old.
研究组 & 干预措施
Ultrasound elastography guided pleural biopsy group
干预措施: Ultrasound elastography guided pleural biopsy (Procedure)
Traditional ultrasound-guided pleural biopsy group
干预措施: Traditional ultrasound guided pleural biopsy (Procedure)
结局指标
主要结局
Efficacy of ultrasound elastography guided pleural biopsy versus traditional ultrasound-guided pleural biopsy for diagnosis of pleural effusion.
时间窗: 7 days after the biopsy
The diagnosis would be confirmed according to the pathological results.
次要结局
- Incidence rate of adverse events(7 days after the biopsy)
研究者
Gang Hou
Principal Investigator
China-Japan Friendship Hospital