Status:
COMPLETED
A Prospective, Randomized Controlled Trial for a Rapid Pleurodesis Protocol for the Management of Pleural Effusions
Lead Sponsor:
Singapore General Hospital
Conditions:
Malignant Pleural Effusions
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Background: Malignant pleural effusions form a significant proportion of respiratory and oncology work-load. The efficacy of thoracoscopic talc poudrage which is the current standard of care is limit...
Detailed Description
Malignant effusions are the 2nd commonest cause of exudative effusions and 75% are due to lung, breast and lymphoma primaries. It is estimated that effusions take up about 20% of pulmonologists' work....
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients aged ≥ 18 with suspected or known symptomatic malignant pleural effusions (i.e. age \>60 or smoking history \> 20 pack years or moderate effusion \>1/3 hemithorax)
- Ability and willingness to sign informed consent. See Annex 1 for patient information sheet and informed consent form.
- Absence of contraindications to thoracoscopy and tunnelled pleural catheters
- Willingness to comply with follow-up i.e. outpatient follow-up at 1 week and at 1 month for standard intervention; and additional every other day drainage in the intervention group (up to 5 times).
- Exclusion criteria:
- Uncorrected coagulopathy with platelet count ≤ 60 and INR ≥ 1.5.
- Uncontrolled coughing because of risk of lung puncture and air leaks
- Severe hypoxemia with a PaO2/FiO2 ratio ≤ 200 or hypercapnia with a PaCO2 ≥ 60 mmHg.
- Unstable cardiovascular status ie. hemodynamic instability requiring inotropes/vasopressors, recent myocardial infarction \< 5 days or uncontrolled arrythmias
- Uncontrolled psychiatric disorders or absence of a significant caregiver both of which will contraindicate sending the patient home with a tunnelled catheter
- Previous thoracic surgery/intervention to the affected hemothorax which may have obliterated the pleural space
- Local skin infections that prevent long term catheter placement
- Morbid obesity which will increase risks associated with moderate sedation in the endoscopy centre
- Multi-loculated effusions that will not benefit from drainage
- Suspected pregnancy
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00758316
Start Date
September 1 2008
End Date
June 1 2013
Last Update
February 10 2017
Active Locations (1)
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1
Sinagpore General Hospital
Singapore, Singapore, 169608