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

Not Applicable

Recruiting

• Conditions: Malignant Pleural Effusion; Thoracic Cancer
• Interventions: Procedure: VATS-Surgical pleurodesis; Procedure: Tube Drainage

• Registration Number: NCT05872126
• Lead Sponsor: Assiut University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Status Verified: 2023-05
• Study First Submitted: 2023-05-13
• Study First Submitted QC: 2023-05-22
• Last Update Submitted: 2023-05-22
• Study First Posted: 2023-05-24
• Last Update Posted: 2023-05-24
• Primary Completion: 2025-03-31
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1-patients with symptomatic malignant pleural effusion. 2- symptomatic patients with shortness of breath. 3-Lung can be fully expanded.

Exclusion Criteria

1. Patients with non symptomatic malignant pleural effusion
2. Pleural symphysis with no potentiality for re-expansion
3. Patients managed surgically through open thoracotomy.
4. Pleural effusion due to causes other than malignancy
5. Loculated malignant effusion judged by chest ultrasound
6. Trapped lung due to malignant pleural effusion assessed by multislice CT chest.,
7. .Refusal to share the research project and not to sign the consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VATS surgical pleurodesis	VATS-Surgical pleurodesis	Patients in whom we use VATS-surgical pleurodesis for malignant pleural effusion.
Tube drainage	Tube Drainage	Patients in whom we use tube drainage for malignant pleural effusion.

Primary Outcome Measures

Name	Time	Method
duration of airleak	3 months postoperative	duration in days
Total hospital stay	3 months postoperative	duration of hospital stay in days

Secondary Outcome Measures

Name	Time	Method
Status of performance	3 months	patient reported outcome through a pre-prepared questionnaire
Failure of management	3 months	time to re-collection
mortality	'3 months	Rate of mortality

Trial Locations

Locations (1)

Assiut university heart hospital; 🇪🇬 Assiut, Egypt