Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion

This study has been completed.
Information provided by:
University of Sao Paulo Identifier:
First received: November 10, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
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.

Condition Intervention Phase
Recurrent Malignant Pleural Effusion.
Procedure: Videothoracoscopic talc poudrage (VT).
Procedure: Talc slurry through a chest tube (DT).
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analysis of Clinical and Radiological Results of Two Methods of Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Radiological lung expansion after talc pleurodesis and clinical outcome [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Clinical efficacy, safety, quality of life and survival. [ Time Frame: 6 months ]

Enrollment: 60
Study Start Date: January 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00789087

University of São Paulo Medical School
São Paulo, Brazil, 01246903
Sponsors and Collaborators
University of Sao Paulo
Principal Investigator: Ricardo M. Terra, MD University of Sao Paulo
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ricardo M. Terra, University of São Paulo Medical School Identifier: NCT00789087     History of Changes
Other Study ID Numbers: 1105/04
Study First Received: November 10, 2008
Last Updated: November 10, 2008

Keywords provided by University of Sao Paulo:
Pleural Effusion.
Quality of Life.

Additional relevant MeSH terms:
Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms processed this record on May 25, 2017