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

Malignant Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05872126
• Other study ID #: AssiutMedicCTS
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2023
• Source: Assiut University
• Contact: Kareem A Hosny, M.SC
• Phone: 01000401994
• Email: kareemdna94[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant
• Thoracic Cancer

Intervention

Procedure:
• VATS-Surgical pleurodesis
VATS drainage and surgical abrasion.
• Tube Drainage
Tube drainage for malignant pleural effusion

Locations

Country	Name	City	State
Egypt	Assiut university heart hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total hospital stay	duration of hospital stay in days	3 months postoperative
Primary	duration of airleak	duration in days	3 months postoperative
Secondary	Status of performance	patient reported outcome through a pre-prepared questionnaire	3 months
Secondary	mortality	Rate of mortality	'3 months
Secondary	Failure of management	time to re-collection	3 months