Status:
COMPLETED
The First Therapeutic Intervention in Malignant Pleural Effusion Trial
Lead Sponsor:
University of California, Davis
Conditions:
Malignant Pleural Effusion
Pleural Effusion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Fluid caused by cancer cells may accumulate in the lining of the lung. Draining the fluid with a chest tube may relieve pain and shortness of breath. To stop the fluid from coming back again, patients...
Detailed Description
Patients with metastatic cancer often have fluid collecting around the lung as a result of cancer cells spreading to the membranes adjacent to the lung (malignant pleural effusion). The standard way o...
Eligibility Criteria
Inclusion
- Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis. The diagnosis may be established by one of:
- Histologically proven pleural malignancy OR
- Typical features of pleural malignancy seen on direct vision during thoracoscopy OR
- Pleural effusion in the context of histologically proven cancer elsewhere
- Expected survival more than 1 month
- Written informed consent
Exclusion
- Age \< 18 years
- Primary lymphoma or small cell lung carcinoma
- Patients who are pregnant or lactating
- Inability to give informed consent
- History of GI bleeding or of untreated peptic ulceration
- Known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs)/opiates/acetaminophen
- Hypercapnic respiratory failure
- Known intravenous drug abuse
- Severe renal or liver disease
- Known bleeding diathesis
- Warfarin therapy
- Current or recent (within 2 weeks) corticosteroid steroid therapy
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00896285
Start Date
April 1 2009
End Date
December 1 2014
Last Update
July 20 2015
Active Locations (1)
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1
UC Davis Medical Center
Sacramento, California, United States, 95817