Video-assisted Hyperthermic Pleural Chemoperfusion vs Talc Pleurodesis for Refractory Malignant Pleural Effusions.

Study Overview
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Brief Summary
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Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural effusions, in terms of safety and efficacy.

Detailed Description
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The study compares prospectively two groups of patients with refractory maignant pleural effusion. Group A consists of patients undergoing video-assisted hyperthermic pleural chemoperfusion (with a pump machine) and group B includes patients undergoing bed-side tube thoracostomy and talc slurry pleurodesis.

Official Title
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Video-assisted Hyperthermic Pleural Chemoperfusion Versus Bed-side Talc Slurry Pleurodesis for Refractory Malignant Pleural Effusions.

Conditions
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Safety of Intervention, Efficacy of Intervention, Cost Effectiveness

Intervention / Treatment
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* Procedure: VATS hyperthermic chemoperfusion
* Procedure: Bedside talc slurry pleurodesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recurrent symptomatic malignant pleural effusion No prior intrapleural therapy Abscence of bronchial obstruction or fibrosis preventing lung reexpansion No systemic chemotherapy immediately prior to or during the first 30-day interval following pleurodesis Exclusion Criteria: Poor Karnofsky Performance Status

Ages Eligible for Study
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Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VATS hyperthermic pleural chemoperfusion<br>The patients undergo a VATS drainage of pleural effusion with adhesiolysis and complete mobilization of the lung, following by a 1 hour hyperthermic (40oC)chemoperfusion by means of a pump machine. | Procedure: VATS hyperthermic chemoperfusion<br>* VATS, adhesiolysis, hyperthermic chemoperfusion (with a pump machine)<br>|
| Active Comparator: Bedside talc slurry pleurodesis<br>The patients undergo tube thoracostomy under local anesthesia. When the lung is fully expanded, talc slurry bed-side pleurodesis is performed. | Procedure: Bedside talc slurry pleurodesis<br>* Bedside tube thoracostomy under local anesthesia. Bedside talc slurry pleurodesis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of pleural effusion |  | 2 months following intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity |  | Postoperative period (7 days following intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pleural effusion, VATS, hyperthermia, thoracostomy, pleurodesis