Malignant Pleural Effusion: Pleur-X vs. Chemical Pleurodesis in VATS

Study Overview
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Brief Summary
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This is a prospective randomized study whose aim is to compare the efficacy of the permanent thoracic catheter (Pleur-X) versus chemical pleurodesis in videothoracoscopy (VATS) in the treatment of malignant pleural effusion at the first diagnosis.Patients with malignant pleural effusion for whom there is indication of surgery and who agree to participate in the study will be randomized 1: 1 in the Pleur-X arm (arm 1) or in the chemical pleurodesis arm (arm 2). The arm 1 provides for the installation of a permanent drainage under local anesthesia while the arm 2 provides a pleurodesis with talc in VATS under general anesthesia. Both procedures are standard of care.

Detailed Description
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Before the study procedure the patients will be requested to perform some examination as physical and radiological examination. Patients will also complete questionnaires for quality of life assessment (EORTC QLQ 30) and symptoms (VAS for pain). Patients will then be randomized into one of the two arms. For patients included in arm 1, a permanent drainage (Pleur-X) is provided under local anesthesia performed on an outpatient basis while for patients included in arm 2 a pleurodesis with talc in VATS is planned under general anesthesia. Arm 2 patients will be hospitalized for 5 days. Patients will then be followed up to 3 months after surgery. During this period a medical examination will be required at 1 week, 4 weeks and 3 months after the intervention during which the patient will be asked to complete questionnaires for the evaluation of quality of life (EORTC QLQ 30) and symptoms (VAS for pain ). A chest radiograph will be performed after four weeks to evaluate the primary parameter. Adverse events will be collected throughout the study period.

Official Title
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Randomized Clinical Trial to Evaluate the Efficacy of the Permanent Thoracic Catheter (Pleur-X) Towards Pleurodesis in Thoracoscopy in the Treatment of Malignant Pleural Effusion

Conditions
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Malignant Pleural Effusion

Intervention / Treatment
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* Procedure: Pleur-X
* Procedure: Pleurodesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years, <80 years First diagnosis of malignant pleural effusion Indication to treat the malignant pleural effusion with surgery Informed informed consent Exclusion Criteria: Previous surgeries on the same hemitorace Pregnant women Trapped lung syndrome Patients with estimated life expectancy < 4-8 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: Pleur-X<br>Placement of a permanent drainage under local anesthesia | Procedure: Pleur-X<br>* Permanent drainage<br>|
| Experimental: pleurodesis<br>Pleurodesis with talc in VATS | Procedure: Pleurodesis<br>* Pleurodesis with talc in permanent VATS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of the treatment with VPM | Evaluate the success rate of the treatment with VPM with radiological examination | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event | Evaluate the tollerability of both procedures collecting adverse events | 3 months | 
| Quality of live | quality of live will be determined with the evaluation of the EORTC QLQ 30 questionnaire | 3 months | 
| Pain scale | Pain will be evaluated with the Visual Analogue Scale (VAS) where the score of 0 is no pain while the score 10 is very painfull | 3 months |