Clinical Trial: Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Analysis of Clinical and Radiological Results of Two Methods of Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion
Brief Summary: The purpose of this study is to analyze and compare radiological lung expansion after talc pleurodesis performed either by videothoracoscopy or chest tube and correlate it with clinical outcome. Secondary endpoints evaluated were: clinical efficacy, safety, quality of life and survival.
Detailed Summary:
Talc pleurodesis is the most popular method to control symptoms of recurrent malignant pleural effusion. The intrapleural talc delivery may be by videothoracoscopy and talc poudrage or talc slurry thought a chest tube and the best method is still controversial. Although the lung expansion is a key criteria for success of the procedure, its characteristics are poorly studied.
Patients were enrolled into two groups: videothoracoscopic talc poudrage (VT) and talc slurry through a chest tube (DT). Lung expansion was evaluated through chest CT scans obtained obtained in the first 7 days and 1, 3 and 6 months after pleurodesis. All examinations were revised by two independent observers. Clinical efficacy (considered as lack of new procedures during follow up), complications, drainage duration, hospital stay and quality of life (general and specific questionnaires) were also analyzed.
Sponsor: University of Sao Paulo
Current Primary Outcome: Radiological lung expansion after talc pleurodesis and clinical outcome [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Clinical efficacy, safety, quality of life and survival. [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: University of Sao Paulo
Dates:
Date Received: November 10, 2008
Date Started: January 2005
Date Completion:
Last Updated: November 10, 2008
Last Verified: November 2008
