Randomized Trial of Tunneled Pleural Catheter Versus Standard Chest Tube in Management of Malignant Pleural Effusion in Patients With Partial Entrapment of the Lung
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- global quality scale QL2
研究概览
简要总结
An open randomized, prospective, single center; parallel group trial to compare efficiency and safety of PleurX-Pleural Catheter versus standard surgical treatment in patients with malignant pleural effusion and partial entrapment of the lung.
详细描述
Patients with malignant pleural effusions undergo VATS-procedure. In the intraoperative finding of a partially entrapped lung, patients are randomized in 2 groups.
Arm 1: Insufflation of talc and insertion of a (standard) drainage which will be removed 4-7 days after surgery.
Arm 2: Insufflation of talc and insertion of a (standard) drainage which will be removed 4-7 days after surgery. Additionally, a subcutaneous tunneled catheter will be inserted and will remain in situ
Follow up period is 3 Months
Primary objective is the comparison of quality of life between the 2 arms.
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
- Single (Investigator)
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
- •One-sided malignant pleural effusion, first occurrence, or following repeated pleuracentesis
- •History of dyspnea relieved after pleuracentesis
- •Patient is suitable for VATS
- •Surgery is indicated by diagnostic necessity
- •Ability of subject to understand character and individual consequences of clinical trial
- •Written informed consent must be available before enrolment in the trial
- •For women with childbearing potential, adequate contraception.
- •Histological proven pleural carcinosis by immediate sectioning
- •Intraoperative: partial entrapment of the lung
排除标准
- •Prior lobectomy or pneumonectomy on the affected side
- •The patient is not operable for general reasons or Karnofsky performance score < 50
- •Intraoperative suspicion of a pleural empyema
- •Chylothorax
- •Prior attempts at pleurodesis
- •Intended or prior intrapleural chemotherapy or radiotherapy
- •Pregnancy and lactation
- •Participation in other competing clinical trials and observation period of competing trials
结局指标
主要结局
global quality scale QL2
时间窗: 3 months
次要结局
- clinical parameters (respiratory function measured as FEV1 and vital capacity, recurrent pleural effusion, infection, need for relief of effusion or pleuracentesis)(3 months)
研究者
Felix JF Herth
Head
Heidelberg University