Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion
Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Recurrent Malignant Pleural Effusion.
Intervention: Videothoracoscopic talc poudrage (VT). (Procedure); Talc slurry through a chest tube (DT). (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: University of Sao Paulo Official(s) and/or principal investigator(s):
Ricardo M. Terra, MD, Principal Investigator, Affiliation: University of Sao Paulo
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.
Clinical Details
Official title: Analysis of Clinical and Radiological Results of Two Methods of Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Radiological lung expansion after talc pleurodesis and clinical outcome
Secondary outcome: Clinical efficacy, safety, quality of life and survival.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Malignant pleural effusion confirmed by cytological analysis of pleural fluid and/or
pleural biopsy;
- Recurrent pleural effusion with symptoms;
- Chest radiography with lung expansion after thoracocentesis;
- Karnofsky Performance Status > 70;
- Written informed patient consent were obtained.
Exclusion Criteria:
- Hemorrhagic diathesis;
- Active infection;
- Cutaneous infiltration;
- Patients unable to understand the questionnaires;
- Age: > 90 yo or < 18 yo.
Locations and Contacts
University of São Paulo Medical School, São Paulo 01246903, Brazil
Additional Information
Starting date: January 2005
Last updated: November 10, 2008
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