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

Duke University

Status and phase: Completed; Phase 4

Conditions: Pleural Effusion, Malignant

Treatments: Other: Aggressive Drainage Instructions; Other: Standard Drainage Instructions

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00978939

Pro00016092

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 150 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Aggressive Drainage Arm

Experimental group

Description:

Patients will drain up to 1 liter of pleural fluid everyday

Treatment:

Other: Aggressive Drainage Instructions

Standard Drainage Arm

Active Comparator group

Description:

Patients will drain up to 1 liter of pleural fluid every other day

Treatment:

Other: Standard Drainage Instructions