Impact of Aggressive Versus Standard Drainage Regimen Using a Long Term Indwelling Pleural Catheter on the Incidence of Auto-Pleurodesis in Patients With Malignant Pleural Effusions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- To compare the incidence of auto-pleurodesis utilizing aggressive drainage versus standard drainage protocols with the PleuRx® catheter
研究概览
简要总结
Purpose and Objective: The purpose of this study is to determine if the rate of spontaneous pleurodesis using the Pleurx® catheter could be increased by simply increasing the frequency of pleural drainage and, if so, whether catheter-related complications can be minimized and spare patients the need for long term management of the Pleurx® catheter.
详细描述
Study Population: Patients greater than 18 years of age with malignant pleural effusions will be identified and approached in clinic by the Principle and Co-Investigator. Informed consent will be obtained from qualified and interested patients.
Study Activities: Patients will be randomized to standard and aggressive drainage groups and complete questionnaires regarding their health. Patients will then receive the Pleurx® catheter for standard treatment of their malignant pleural effusions, obtain a chest-xray, and receive educational instruction and training on catheter drainage and told whether to drain everyday using a 1-liter bottle or every other day using a 600-cc bottle. Patients will complete a drainage diary on everyday they drain fluid which will provide information on drainage volume, fluid color, pain, and complications. At 2 weeks, 6 weeks, and 12 weeks post catheter placement, patients will return to clinic for follow-up at which time they will have an interval history and physical and chest xray and complete a questionnaires regarding their health and satisfaction.
Risks/Safety Issues: Risks associated with draining the catheter include: pneumothorax, re-expansion pulmonary edema, hypotension, circulatory collapse, and infection. All serious adverse events will be reported to the institutional review board: a) death - immediately; b) life-threatening within 7 calendar days; c) all other SAEs (serious adverse events) within 15 calendar days. Should there be a serious adverse event that occurs that increases the risk to the participants, the study will be stopped, an investigation will be conducted, and a findings report will be generated before the study is resumed.
Data Analysis: The principal endpoint is the incidence of successful pleurodesis utilizing an aggressive drainage protocol compared to the incidence of successful pleurodesis using a standard drainage protocol. An interim analysis will be performed after 3 months.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years old
- •Pleural effusion (etiology fulfilling one of the following criteria):
- •Malignant effusion confirmed by cytology or pleural biopsy
- •Exudative effusion in the setting of known malignancy with no other identifiable cause
- •Malignant effusion due to tumors that are historically rapidly responsive to systemic therapy (small cell lung cancer, hematological malignancies) will only be included if refractory to standard chemotherapy
- •Symptoms such as shortness of breath, cough, or chest fullness/chest discomfort
- •Age greater than 18 years old
- •Pleural effusion (etiology fulfilling one of the following criteria):
- •Demonstration of symptomatic improvement after therapeutic thoracentesis (removal of ≤ 1.5 L of pleural fluid)
- •Recurrent pleural effusion after therapeutic thoracentesis
排除标准
- •Projected life expectancy less than 30 days as predicted by Karnofsky Performance Status score less than 30
- •Radiographic evidence of trapped lung - persistent lung collapse with failure of the lung to reexpand following drainage of a pleural effusion
- •Radiographic evidence of loculated pleural fluid
- •Previous attempted pleurodesis on the affected side
- •Previous lobectomy or pneumonectomy on the affected side
- •Patient receiving intrapleural chemotherapy
- •Chylothorax - pleural effusion with triglyceride levels > 110 mg/dl or chylomicrons on lipoprotein analysis, most commonly due to trauma/obstruction of the thoracic duct
- •Parapneumonic effusion - pleural effusion associated with pneumonia
- •Empyema - infected pleural space as defined by purulent pleural fluid, positive gram stain, or positive culture
- •Inability to adequately perform pleural drainage at home
- •Uncorrectable bleeding disorder
- •Skin infection at the site of intended catheter insertion
结局指标
主要结局
To compare the incidence of auto-pleurodesis utilizing aggressive drainage versus standard drainage protocols with the PleuRx® catheter
时间窗: 2, 6, and 12 weeks post-catheter insertion
次要结局
- To determine the median time to auto-pleurodesis utilizing aggressive drainage versus standard drainage protocols with the PleuRx® catheter(2, 6, and 12 weeks post-catheter insertion)
- To determine patient and caregivers' satisfaction with the PleuRx® catheter using a questionnaire(2, 6, and 12 weeks post-catheter insertion)
- To determine predictors of auto-pleurodesis (volume and rate of pleural fluid drainage, biochemical, and radiographic) using post-hoc analysis in both the aggressive and standard drainage protocols(2, 6, and 12 weeks post-catheter insertion)
- To assess the effects of aggressive drainage versus standard drainage protocols with the PleuRx® catheter on functional health status(2, 6, and 12 weeks post-catheter insertion)