Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Recurrent Malignant Pleural Effusion.

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00789087

1105/04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

1. Videothoracoscopic talc poudrage (VT)

Active Comparator group

Treatment:

Procedure: Videothoracoscopic talc poudrage (VT).

2. Talc slurry through a chest tube (DT)

Active Comparator group

Treatment:

Procedure: Talc slurry through a chest tube (DT).