Status:
COMPLETED
Impact of Aggressive Versus Standard Drainage Regimen Using a Long Term Indwelling Pleural Catheter
Lead Sponsor:
Duke University
Collaborating Sponsors:
C. R. Bard
Conditions:
Pleural Effusion, Malignant
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
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 drai...
Detailed Description
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 obta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00978939
Start Date
August 1 2009
End Date
October 1 2013
Last Update
December 30 2013
Active Locations (6)
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1
National Jewish Medical Center
Denver, Colorado, United States, 80206
2
Johns Hopkins University
Baltimore, Maryland, United States, 21287
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
Lahey Clinic
Burlington, Massachusetts, United States, 01805