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
18 Years
N/A
Both
Malignant Pleural Effusion
Trial Information
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.
Inclusion Criteria:
1. Presence of symptomatic and moderate sized (>1/3 of hemithorax) MPE
2. Persistent malignant pleural effusion that is free-flowing
3. Symptomatic improvement after therapeutic thoracentesis
4. Life expectancy of at least three months (duration of study follow-up)
5. 90% radiographic apposition of parietal and visceral pleura
6. Residence within 30 minute radius from The Ottawa Hospital
Exclusion Criteria:
1. Previous lobectomy or pneumonectomy on affected side
2. Multiple loculations
3. Trapped or entrapped lung
4. Untreated pleural infection
5. Abnormal coagulation profile (INR>1.5 and / or platelet count <50 x 10*9/L)
6. Planned intrapleural chemotherapy (however participants may receive concomitant
systemic chemotherapy, mediastinal radiation therapy or steroids)
7. Life expectancy less than 3 months
8. Multiple co-morbidities limiting out-patient management of pleural effusion
9. Tetracycline / Doxycycline allergy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Time to pleurodesis
Outcome Description:
measured in days after Pleurx catheter insertion up to 90 days
Outcome Time Frame:
up to 90 days post PleurX insertion
Safety Issue:
No
Principal Investigator
K. Amjadi, MD, FRCPC
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ottawa Hospital
Authority:
Canada: Health Canada
Study ID:
2008362-01H
NCT ID:
NCT01411202
Start Date:
June 2011
Completion Date:
September 2012
Related Keywords:
- Malignant Pleural Effusion
- Malignant Pleural Effusion
- Doxycycline
- Pleurodesis
- Pleurx catheter
- Pleural Effusion
- Pleural Effusion, Malignant
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