Video-assisted Hyperthermic Pleural Chemoperfusion Versus Bed-side Talc Slurry Pleurodesis for Refractory Malignant Pleural Effusions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recurrence of pleural effusion
研究概览
简要总结
Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural effusions, in terms of safety and efficacy.
详细描述
The study compares prospectively two groups of patients with refractory maignant pleural effusion. Group A consists of patients undergoing video-assisted hyperthermic pleural chemoperfusion (with a pump machine) and group B includes patients undergoing bed-side tube thoracostomy and talc slurry pleurodesis.
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
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent symptomatic malignant pleural effusion
- •No prior intrapleural therapy
- •Abscence of bronchial obstruction or fibrosis preventing lung reexpansion
- •No systemic chemotherapy immediately prior to or during the first 30-day interval following pleurodesis
排除标准
- •Poor Karnofsky Performance Status
研究组 & 干预措施
VATS hyperthermic pleural chemoperfusion
The patients undergo a VATS drainage of pleural effusion with adhesiolysis and complete mobilization of the lung, following by a 1 hour hyperthermic (40oC)chemoperfusion by means of a pump machine.
干预措施: VATS hyperthermic chemoperfusion (Procedure)
Bedside talc slurry pleurodesis
The patients undergo tube thoracostomy under local anesthesia. When the lung is fully expanded, talc slurry bed-side pleurodesis is performed.
干预措施: Bedside talc slurry pleurodesis (Procedure)
结局指标
主要结局
Recurrence of pleural effusion
时间窗: 2 months following intervention
次要结局
- Morbidity(Postoperative period (7 days following intervention))
研究者
Nikolaos Barbetakis
Head of Thoracic Surgery Department
Theagenio Cancer Hospital