Analysis of Clinical and Radiological Results of Two Methods of Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Radiological lung expansion after talc pleurodesis and clinical outcome
研究概览
简要总结
The purpose of this study is to analyze and compare radiological lung expansion after talc pleurodesis performed either by videothoracoscopy or chest tube and correlate it with clinical outcome. Secondary endpoints evaluated were: clinical efficacy, safety, quality of life and survival.
详细描述
Talc pleurodesis is the most popular method to control symptoms of recurrent malignant pleural effusion. The intrapleural talc delivery may be by videothoracoscopy and talc poudrage or talc slurry thought a chest tube and the best method is still controversial. Although the lung expansion is a key criteria for success of the procedure, its characteristics are poorly studied.
Patients were enrolled into two groups: videothoracoscopic talc poudrage (VT) and talc slurry through a chest tube (DT). Lung expansion was evaluated through chest CT scans obtained obtained in the first 7 days and 1, 3 and 6 months after pleurodesis. All examinations were revised by two independent observers. Clinical efficacy (considered as lack of new procedures during follow up), complications, drainage duration, hospital stay and quality of life (general and specific questionnaires) were also analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Malignant pleural effusion confirmed by cytological analysis of pleural fluid and/or pleural biopsy;
- •Recurrent pleural effusion with symptoms;
- •Chest radiography with lung expansion after thoracocentesis;
- •Karnofsky Performance Status > 70;
- •Written informed patient consent were obtained.
排除标准
- •Hemorrhagic diathesis;
- •Active infection;
- •Cutaneous infiltration;
- •Patients unable to understand the questionnaires;
- •Age: > 90 yo or < 18 yo.
结局指标
主要结局
Radiological lung expansion after talc pleurodesis and clinical outcome
时间窗: 6 months
次要结局
- Clinical efficacy, safety, quality of life and survival.(6 months)