Randomized Clinical Trial to Evaluate the Efficacy of the Permanent Thoracic Catheter (Pleur-X) Towards Pleurodesis in Thoracoscopy in the Treatment of Malignant Pleural Effusion
试验速览
- 阶段
- 不适用
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- Success rate of the treatment with VPM
研究概览
简要总结
This is a prospective randomized study whose aim is to compare the efficacy of the permanent thoracic catheter (Pleur-X) versus chemical pleurodesis in videothoracoscopy (VATS) in the treatment of malignant pleural effusion at the first diagnosis.Patients with malignant pleural effusion for whom there is indication of surgery and who agree to participate in the study will be randomized 1: 1 in the Pleur-X arm (arm 1) or in the chemical pleurodesis arm (arm 2).
The arm 1 provides for the installation of a permanent drainage under local anesthesia while the arm 2 provides a pleurodesis with talc in VATS under general anesthesia.
Both procedures are standard of care.
详细描述
Before the study procedure the patients will be requested to perform some examination as physical and radiological examination. Patients will also complete questionnaires for quality of life assessment (EORTC QLQ 30) and symptoms (VAS for pain). Patients will then be randomized into one of the two arms.
For patients included in arm 1, a permanent drainage (Pleur-X) is provided under local anesthesia performed on an outpatient basis while for patients included in arm 2 a pleurodesis with talc in VATS is planned under general anesthesia. Arm 2 patients will be hospitalized for 5 days.
Patients will then be followed up to 3 months after surgery. During this period a medical examination will be required at 1 week, 4 weeks and 3 months after the intervention during which the patient will be asked to complete questionnaires for the evaluation of quality of life (EORTC QLQ 30) and symptoms (VAS for pain ). A chest radiograph will be performed after four weeks to evaluate the primary parameter. Adverse events will be collected throughout the study period.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, <80 years
- •First diagnosis of malignant pleural effusion
- •Indication to treat the malignant pleural effusion with surgery
- •Informed informed consent
排除标准
- •Previous surgeries on the same hemitorace
- •Pregnant women
- •Trapped lung syndrome
- •Patients with estimated life expectancy < 4-8 weeks
研究组 & 干预措施
pleurodesis
Pleurodesis with talc in VATS
干预措施: Pleurodesis (Procedure)
Pleur-X
Placement of a permanent drainage under local anesthesia
干预措施: Pleur-X (Procedure)
结局指标
主要结局
Success rate of the treatment with VPM
时间窗: 4 weeks
Evaluate the success rate of the treatment with VPM with radiological examination
次要结局
- Adverse Event(3 months)
- Quality of live(3 months)
- Pain scale(3 months)
研究者
Rolf Inderbitzi
Head of thoracic surgery department
Ente Ospedaliero Cantonale, Bellinzona