Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion

Recurrent Malignant Pleural Effusion. Clinical Trial

Official title:

Analysis of Clinical and Radiological Results of Two Methods of Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789087
• Other study ID #: 1105/04
• Status: Completed
• Phase: Phase 4
• First received: November 10, 2008
• Last updated: November 10, 2008
• Start date: January 2005
• Est. completion date: January 2008

Study information

• Verified date: November 2008
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pleural Effusion
• Pleural Effusion, Malignant
• Recurrent Malignant Pleural Effusion.

Intervention

Procedure:
• Videothoracoscopic talc poudrage (VT).
Videothoracoscopic talc poudrage
• Talc slurry through a chest tube (DT).
Talc slurry through a chest tube

Locations

Country	Name	City	State
Brazil	University of São Paulo Medical School	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological lung expansion after talc pleurodesis and clinical outcome		6 months	Yes
Secondary	Clinical efficacy, safety, quality of life and survival.		6 months	Yes