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

• Sponsor: Assiut University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05872126
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 25
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Malignant Pleural Effusion; Thoracic Cancer	Procedure: VATS-Surgical pleurodesis; Procedure: Tube Drainage	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomised Clinical Trial with 2 groups; Case group for VATS mechanical abrasion and Control group for tube drainageRandomised Clinical Trial with 2 groups; Case group for VATS mechanical abrasion and Control group for tube drainage
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Video Assisted Thoracoscopic Surgery (VATS) - Surgical Pleurodesis vs Tube Drainage in Management of Malignant Pleural Effusion (MPE)
• Actual Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Mar 31, 2025
• Anticipated Study Completion Date: Apr 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: VATS surgical pleurodesis Patients in whom we use VATS-surgical pleurodesis for malignant pleural effusion.	Procedure: VATS-Surgical pleurodesis; VATS drainage and surgical abrasion.
Other: Tube drainage Patients in whom we use tube drainage for malignant pleural effusion.	Procedure: Tube Drainage; Tube drainage for malignant pleural effusion

Outcome Measures

Primary Outcome Measures

1. Total hospital stay [3 months postoperative]

   duration of hospital stay in days

2. duration of airleak [3 months postoperative]

   duration in days

Secondary Outcome Measures

1. Status of performance [3 months]

   patient reported outcome through a pre-prepared questionnaire

2. mortality ['3 months]

   Rate of mortality

3. Failure of management [3 months]

   time to re-collection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university heart hospital	Assiut		Egypt	2112

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kareem Ahmed Hosny, Principle investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT05872126
• Other Study ID Numbers: AssiutMedicCTS
• First Posted: May 24, 2023
• Last Update Posted: May 24, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kareem Ahmed Hosny, Principle investigator, Assiut University: Malignant pleural effusion; VATS; PleurX; Abrasion
• Additional relevant MeSH terms: Pleural Effusion, Malignant; Pleural Effusion

Study Results

No Results Posted as of May 24, 2023