Randomised Controlled Trial Comparing Outpatient Management of Malignant Pleural Effusion Via an Indwelling Pleural Catheter and Talc Pleurodesis Versus Standard Inpatient Management in Improving Health Related Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Global health-related quality of life
研究概览
简要总结
This is a multicentre randomised controlled trial evaluating global health related quality of life outcomes in patients with malignant pleural effusions. Patients will be randomised to receive either chest drain and talc pleurodesis or indwelling pleural catheter and talc pleurodesis. Patients will be followed up for 3 months post intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of malignant pleural effusion
- •WHO performance status 2 or less unless performance status is impaired by presence of effusion and likely to significantly improve with drainage
- •Expected survival greater than 3 months
排除标准
- •Age less than 18 years old
- •Pregnant or lactating
- •Known allergy to Talc or Lignocaine
- •Lack of symptomatic relief from effusion drainage
- •At least twice weekly drainage cannot be undertaken
- •Lymphoma or small cell carcinoma except*:
- •Failure of chemotherapy
- •Deemed for palliative management
- •Non malignant effusions
- •Loculated pleural effusion
- •Unable to provide written informed consent to trial participation
研究组 & 干预措施
Usual Care Group
Patients in this group will be managed as per the British Thoracic Society guideline for management of malignant pleural effusions. They will undergo chest tube insertion and undergo Talc pleurodesis with 4g of SteriTalc
干预措施: Chest Drain Insertion and Talc Pleurodesis (Device)
Indwelling Pleural Catheter Group
Patients in this group will undergo Indwelling Pleural Catheter (IPC) insertion. This will be inserted as per standard practice. They will undergo Talc pleurodesis via the IPC with 4g SteriTalc
干预措施: Indwelling Pleural Catheter Insertion and Talc Pleurodesis (Device)
结局指标
主要结局
Global health-related quality of life
时间窗: 30 days
Global health related quality of life as measured by EORTC QLQ-C30
次要结局
- Pleurodesis failure rate(30, 60 and 90 days)
- Improvement in symptoms of pain and breathlessness(30, 60 and 90 days)
- Global health-related quality of life(60 and 90 days)
- Complication rate(Day 7, 14, 30, 60 and 90)