Outpatient Pleurodesis Using Sclerosants(OPUS):Comparing Doxycycline Pleurodesis to Continued Drainage With the Pleurx Catheter System in the Treatment of Malignant Pleural Effusions in the Outpatient Setting
Malignant pleural effusions (MPE) occur in 25 - 50% of malignancies, represent advanced
disease and carry with it significant morbidity. It is estimated that 75% of malignant
effusions are symptomatic at the time of presentation, with dyspnea being the most common
complaint. Cough, weight loss and chest pain may also be presenting symptoms. The diagnosis
of MPE often carries with it a poor prognosis with an average survival of 3-9 months. Thus,
management of MPE is generally palliative, aimed at alleviating the associated symptoms,
while incurring minimal discomfort and disruption of patients activities of daily living.
Limiting the number of days spent hospitalized ia also a consideration. Currently, the most
common treatment for MPE involves tube thoracostomy and pleurodesis using a sclerosing
agent. Use of Doxycycline as a sclerosing agent has been shown to be both safe and
efficacious with only minor complications. Traditionally, pleurodesis with Doxycycline has
been performed in the inpatient setting.
The Pleurx catheter (Cardinal Biomedical) is the only small bore catheter commercially
available that has been specifically designed for long term indwelling drainage of MPE. In
order to reduce the chance of dislodgement and minimize infection rates, it is tunnelled
under the skin for approximately 5 cm before entering the pleural space. These indwelling
catheters can provide excellent symptom control and have also been associated with
spontaneous pleurodesis rates comparable to many chemical pleurodesis rates.
Pleurx has been compared to inpatient doxycycline pleurodesis via chest tube with no
difference in survival, safety or efficacy noted. However, hospital stay was significantly
shorter in the Pleurx group, 1 day versus 6.5 days.
The aim of this study is to determine the effectiveness of outpatient pleurodesis, using
doxycycline administered via Pleurx catheter. This will be a randomized clinical trial
comparing the time to pleurodesis in patients with malignant pleural effusion receiving
doxycycline + Pleurx catheter versus Pleurx catheter alone.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Time to pleurodesis
measured in days after Pleurx catheter insertion up to 90 days
up to 90 days post PleurX insertion
K. Amjadi, MD, FRCPC
Canada: Health Canada