Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion
NCT ID: NCT00789087
Last Updated: 2008-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2005-01-31
2008-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1. Videothoracoscopic talc poudrage (VT)
Videothoracoscopic talc poudrage (VT).
Videothoracoscopic talc poudrage
2. Talc slurry through a chest tube (DT)
Talc slurry through a chest tube (DT).
Talc slurry through a chest tube
Interventions
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Videothoracoscopic talc poudrage (VT).
Videothoracoscopic talc poudrage
Talc slurry through a chest tube (DT).
Talc slurry through a chest tube
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Recurrent pleural effusion with symptoms;
* Chest radiography with lung expansion after thoracocentesis;
* Karnofsky Performance Status \> 70;
* Written informed patient consent were obtained.
Exclusion Criteria
* Active infection;
* Cutaneous infiltration;
* Patients unable to understand the questionnaires;
* Age: \> 90 yo or \< 18 yo.
18 Years
90 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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University of São Paulo Medical School
Principal Investigators
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Ricardo M. Terra, MD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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University of São Paulo Medical School
São Paulo, São Paulo, Brazil
Countries
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References
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Terra RM, Junqueira JJM, Teixeira LR, Vargas FS, Pego-Fernandes PM, Jatene FB. Is full postpleurodesis lung expansion a determinant of a successful outcome after talc pleurodesis? Chest. 2009 Aug;136(2):361-368. doi: 10.1378/chest.08-2448. Epub 2009 Apr 6.
Other Identifiers
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1105/04
Identifier Type: -
Identifier Source: org_study_id
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