Research Studies
ASAP (CareFusion/Duke): 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
Status: Active - Enrolling
Contact: Christina Carbone (203) 737-5040
Purpose
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
Inclusion Criteria
Factors that allow someone to participate in a clinical trial.
- 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
- Malignant effusion confirmed by cytology or pleural biopsy
- 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
Factors that do not allow someone to participate in a clinical trial.
- 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