Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion

Phase 4

Completed

• Conditions: Recurrent Malignant Pleural Effusion.
• Interventions: Procedure: Videothoracoscopic talc poudrage (VT).; Procedure: Talc slurry through a chest tube (DT).

• Registration Number: NCT00789087
• Lead Sponsor: University of Sao Paulo

Brief 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.

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.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2008-11
• Study First Submitted: 2008-11-10
• Study First Submitted QC: 2008-11-10
• Last Update Submitted: 2008-11-10
• Study First Posted: 2008-11-11
• Last Update Posted: 2008-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Videothoracoscopic talc poudrage (VT)	Videothoracoscopic talc poudrage (VT).	-
2. Talc slurry through a chest tube (DT)	Talc slurry through a chest tube (DT).	-

Primary Outcome Measures

Name	Time	Method
Radiological lung expansion after talc pleurodesis and clinical outcome	6 months

Secondary Outcome Measures

Name	Time	Method
Clinical efficacy, safety, quality of life and survival.	6 months

Trial Locations

Locations (1)

University of São Paulo Medical School; 🇧🇷 São Paulo, Brazil