Trial Information

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

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.