Indwelling Pleural Catheter for Trapped Lung: a Pilot Study for Power Calculation of a Randomized Controlled Trial Comparing Pleurocath® Versus PleurX®)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS) range 0 (no pain) - 100 (maximum pain)
研究概览
简要总结
Malignant pleural effusion (MPE) is a complication of almost any site of primary cancer as well as primary tumors of the pleura. Half of MPE patients have non-expendable trapped lungs not suitable for talc pleurodesis. Indwelling pleural catheters (IPCs), however, can be used in this cohort of patients, bringing about an improvement in dyspnea and quality of life (QOL).
The aim of this study is to obtain pilot data - comparing patients receiving two different types of indwelling pleural catethers normally used in clinical practice (10 patients receiving Pleurocath® and 10 patients receiving PleurX®) - for power calculation of a Randomized Controlled Trial comparing two different drainages for MPE trapped lung.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, with a clinical confident diagnosis of symptomatic malignant pleural effusion, enrolled for VATS exploration but not amenable of VATS talc poudrage because of trapped lung (patients with only partial expansion however receiving talc poudrage, but needing permanent pleural cathetes, are also eligible)
排除标准
- •- Age younger than 18 years
- •Expected survival of less than 3 months
- •Chylothorax
- •Total white blood cell count less than 1000/microL
- •Pregnancy or lactating mothers
- •Irreversible bleeding diathesis
- •Irreversible visual impairment
- •Contraindications to general anesthesia
- •Poor general clinical conditions ( ECOG PS >=2)
- •Patients unable to provide informed consent
研究组 & 干预措施
PleurX
Positioning of Pleurx drainage during surgical exploration if lung does not reinflate
干预措施: PleurX (Device)
Pleurocath
Positioning of Pleur o cath drainage during surgical exploration if lung does not reinflate
干预措施: Pleurocath (Device)
结局指标
主要结局
Visual Analog Scale (VAS) range 0 (no pain) - 100 (maximum pain)
时间窗: Post operative day 4th
Thoracic pain
Visual Analog Scale (VAS) range 0 (no dyspnea) - 100 (maximim dyspnea)
时间窗: Post operative day 4th
Dyspnea
次要结局
未报告次要终点