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

Completed · Phase 4

Conditions studied: Pleural Effusion, Malignant

In brief

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.

Key facts

Study ID

NCT00978939

Run by

Duke University

People needed

150

Starts

2009-08-01

Expected to finish

2013-10-01

Last updated by the study team

2013-12-30

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• National Jewish Medical Center — Denver, Colorado, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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