Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion - Full Text View

Sponsored by:	University of Sao Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00789087

Purpose

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 IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical efficacy, safety, quality of life and survival. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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
1. Videothoracoscopic talc poudrage (VT): Active Comparator	Procedure: Videothoracoscopic talc poudrage (VT). Videothoracoscopic talc poudrage
2. Talc slurry through a chest tube (DT): Active Comparator	Procedure: Talc slurry through a chest tube (DT). 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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789087

Locations

Brazil
University of São Paulo Medical School
São Paulo, Brazil, 01246903

Sponsors and Collaborators

University of Sao Paulo

Investigators

Principal Investigator:

Ricardo M. Terra, MD

University of São Paulo Medical School

More Information

Responsible Party:	University of São Paulo Medical School ( Ricardo M. Terra )
Study ID Numbers:	1105/04
Study First Received:	November 10, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00789087
Health Authority:	Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:

Pleural Effusion.
Talc.
Pleurodesis.
Quality of Life.
Thoracoscopy.

Study placed in the following topic categories:

Thoracic Neoplasms
Pleural Effusion
Respiratory Tract Diseases
Pleural Diseases

Quality of Life
Pleural Effusion, Malignant
Recurrence
Pleural Neoplasms

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Disease Attributes
Neoplasms by Site
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009