Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion
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|ClinicalTrials.gov Identifier: NCT00789087|
Recruitment Status : Completed
First Posted : November 11, 2008
Last Update Posted : November 11, 2008
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Malignant Pleural Effusion.||Procedure: Videothoracoscopic talc poudrage (VT). Procedure: Talc slurry through a chest tube (DT).||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Analysis of Clinical and Radiological Results of Two Methods of Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2008|
|Active Comparator: 1. Videothoracoscopic talc poudrage (VT)||
Procedure: Videothoracoscopic talc poudrage (VT).
Videothoracoscopic talc poudrage
Other Name: Videothoracoscopic talc poudrage
|Active Comparator: 2. Talc slurry through a chest tube (DT)||
Procedure: Talc slurry through a chest tube (DT).
Talc slurry through a chest tube
Other Name: Talc slurry through a chest tube
- Radiological lung expansion after talc pleurodesis and clinical outcome [ Time Frame: 6 months ]
- Clinical efficacy, safety, quality of life and survival. [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789087
|University of São Paulo Medical School|
|São Paulo, Brazil, 01246903|
|Principal Investigator:||Ricardo M. Terra, MD||University of Sao Paulo|