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.
PI:               Gaetane Michaud, M.D.
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 
  • 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
Age greater than 18 years old 

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