Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Recurrent Malignant Pleural Effusion.

Intervention / Treatment
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* Procedure: Videothoracoscopic talc poudrage (VT).
* Procedure: Talc slurry through a chest tube (DT).


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. Videothoracoscopic talc poudrage (VT)<br> | Procedure: Videothoracoscopic talc poudrage (VT).<br>* Videothoracoscopic talc poudrage<br>* Other names: Videothoracoscopic talc poudrage;|
| Active Comparator: 2. Talc slurry through a chest tube (DT)<br> | Procedure: Talc slurry through a chest tube (DT).<br>* Talc slurry through a chest tube<br>* Other names: Talc slurry through a chest tube;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological lung expansion after talc pleurodesis and clinical outcome |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy, safety, quality of life and survival. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life., Pleural Effusion., Talc., Pleurodesis., Thoracoscopy.