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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 (serious adverse events) 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.

Official Title
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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

Conditions
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Pleural Effusion, Malignant

Intervention / Treatment
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* Other: Standard Drainage Instructions
* Other: Aggressive Drainage Instructions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aggressive Drainage Arm<br>Patients will drain up to 1 liter of pleural fluid everyday | Other: Aggressive Drainage Instructions<br>* Patients will receive specific instructions to drain up to 1 liter of pleural fluid daily<br>* Other names: Daily Drainage;|
| Active Comparator: Standard Drainage Arm<br>Patients will drain up to 1 liter of pleural fluid every other day | Other: Standard Drainage Instructions<br>* Patients will receive specific instructions to drain up to 1 liter of pleural fluid every other day<br>* Other names: Conventional Drainage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the incidence of auto-pleurodesis utilizing aggressive drainage versus standard drainage protocols with the PleuRx® catheter |  | 2, 6, and 12 weeks post-catheter insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the median time to auto-pleurodesis utilizing aggressive drainage versus standard drainage protocols with the PleuRx® catheter |  | 2, 6, and 12 weeks post-catheter insertion | 
| To assess the effects of aggressive drainage versus standard drainage protocols with the PleuRx® catheter on functional health status |  | 2, 6, and 12 weeks post-catheter insertion | 
| To determine predictors of auto-pleurodesis (volume and rate of pleural fluid drainage, biochemical, and radiographic) using post-hoc analysis in both the aggressive and standard drainage protocols |  | 2, 6, and 12 weeks post-catheter insertion | 
| To determine patient and caregivers' satisfaction with the PleuRx® catheter using a questionnaire |  | 2, 6, and 12 weeks post-catheter insertion |