Impact of Aggressive Versus Standard Drainage Regimen Using a Long Term Indwelling Pleural Catheter

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.

Inclusion criteria

• 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

Exclusion criteria

• 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
• Pregnancy