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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


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.


Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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