Video Assisted Thoracoscopic Surgery (VATS) - Surgical Pleurodesis vs Tube Drainage in Management of Malignant Pleural Effusion (MPE)

Study Overview
=================
Brief Summary
-----------------
Malignant Pleural Effusion (MPE) is considered to be a common presentation at malignant tumors representing 15% of all cancer cases. It carries a burden on our patients with dyspnea being the most common symptom in most of cases. Management of symptomatic malignant pleural effusion remains to be a point of debate. Data available from literature shows conflicting results lacking high quality evidence which necsscitates further research work. Options differs to include chemical pleurodesis using medical or surgical talc poudrage or slurry. Surgical intervention with abrasion pleurodesis or pleurectomy using VATS approach has been used in many studies. Using indwelling pleural catheters (IPCs) has also proved comparable efficacy at many clinical trials. In this study we want to help answering this question so that we can add to the current knowledge aiming to offer the best care for those patients

Official Title
-----------------
Video Assisted Thoracoscopic Surgery (VATS) - Surgical Pleurodesis vs Tube Drainage in Management of Malignant Pleural Effusion (MPE)

Conditions
-----------------
Malignant Pleural Effusion, Thoracic Cancer

Intervention / Treatment
-----------------
* Procedure: VATS-Surgical pleurodesis
* Procedure: Tube Drainage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1-patients with symptomatic malignant pleural effusion. 2- symptomatic patients with shortness of breath. 3-Lung can be fully expanded. Exclusion Criteria: Patients with non symptomatic malignant pleural effusion Pleural symphysis with no potentiality for re-expansion Patients managed surgically through open thoracotomy. Pleural effusion due to causes other than malignancy Loculated malignant effusion judged by chest ultrasound Trapped lung due to malignant pleural effusion assessed by multislice CT chest., .Refusal to share the research project and not to sign the consent.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised Clinical Trial with 2 groups; Case group for VATS mechanical abrasion and Control group for tube drainage
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: VATS surgical pleurodesis<br>Patients in whom we use VATS-surgical pleurodesis for malignant pleural effusion. | Procedure: VATS-Surgical pleurodesis<br>* VATS drainage and surgical abrasion.<br>|
| Other: Tube drainage<br>Patients in whom we use tube drainage for malignant pleural effusion. | Procedure: Tube Drainage<br>* Tube drainage for malignant pleural effusion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total hospital stay | duration of hospital stay in days | 3 months postoperative | 
| duration of airleak | duration in days | 3 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Status of performance | patient reported outcome through a pre-prepared questionnaire | 3 months | 
| mortality | Rate of mortality | '3 months | 
| Failure of management | time to re-collection | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malignant pleural effusion, VATS, PleurX, Abrasion