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 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:

1. Age greater than 18 years old

2. 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

3. Symptoms such as shortness of breath, cough, or chest fullness/chest discomfort

4. Age greater than 18 years old

5. 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:

1. Projected life expectancy less than 30 days as predicted by Karnofsky Performance
Status score less than 30

2. Radiographic evidence of trapped lung - persistent lung collapse with failure of the
lung to reexpand following drainage of a pleural effusion

3. Radiographic evidence of loculated pleural fluid

4. Previous attempted pleurodesis on the affected side

5. Previous lobectomy or pneumonectomy on the affected side

6. Patient receiving intrapleural chemotherapy

7. Chylothorax - pleural effusion with triglyceride levels > 110 mg/dl or chylomicrons
on lipoprotein analysis, most commonly due to trauma/obstruction of the thoracic duct

8. Parapneumonic effusion - pleural effusion associated with pneumonia

9. Empyema - infected pleural space as defined by purulent pleural fluid, positive gram
stain, or positive culture

10. Inability to adequately perform pleural drainage at home

11. Uncorrectable bleeding disorder

12. Skin infection at the site of intended catheter insertion

13. Pregnancy