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

Primary Purpose

Malignant Pleural Effusion, Thoracic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
VATS-Surgical pleurodesis
Tube Drainage
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Pleural Effusion focused on measuring Malignant pleural effusion, VATS, PleurX, Abrasion

Eligibility Criteria

5 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut university heart hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

VATS surgical pleurodesis

Tube drainage

Arm Description

Patients in whom we use VATS-surgical pleurodesis for malignant pleural effusion.

Patients in whom we use tube drainage for malignant pleural effusion.

Outcomes

Primary Outcome Measures

Total hospital stay
duration of hospital stay in days
duration of airleak
duration in days

Secondary Outcome Measures

Status of performance
patient reported outcome through a pre-prepared questionnaire
mortality
Rate of mortality
Failure of management
time to re-collection

Full Information

First Posted
May 13, 2023
Last Updated
May 22, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05872126
Brief Title
Video Assisted Thoracoscopic Surgery (VATS) - Surgical Pleurodesis vs Tube Drainage in Management of Malignant Pleural Effusion (MPE)
Official Title
Video Assisted Thoracoscopic Surgery (VATS) - Surgical Pleurodesis vs Tube Drainage in Management of Malignant Pleural Effusion (MPE)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Effusion, Thoracic Cancer
Keywords
Malignant pleural effusion, VATS, PleurX, Abrasion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Clinical Trial with 2 groups; Case group for VATS mechanical abrasion and Control group for tube drainage
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VATS surgical pleurodesis
Arm Type
Other
Arm Description
Patients in whom we use VATS-surgical pleurodesis for malignant pleural effusion.
Arm Title
Tube drainage
Arm Type
Other
Arm Description
Patients in whom we use tube drainage for malignant pleural effusion.
Intervention Type
Procedure
Intervention Name(s)
VATS-Surgical pleurodesis
Intervention Description
VATS drainage and surgical abrasion.
Intervention Type
Procedure
Intervention Name(s)
Tube Drainage
Intervention Description
Tube drainage for malignant pleural effusion
Primary Outcome Measure Information:
Title
Total hospital stay
Description
duration of hospital stay in days
Time Frame
3 months postoperative
Title
duration of airleak
Description
duration in days
Time Frame
3 months postoperative
Secondary Outcome Measure Information:
Title
Status of performance
Description
patient reported outcome through a pre-prepared questionnaire
Time Frame
3 months
Title
mortality
Description
Rate of mortality
Time Frame
'3 months
Title
Failure of management
Description
time to re-collection
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kareem A Hosny, M.SC
Phone
01000401994
Email
kareemdna94@gmail.com
Facility Information:
Facility Name
Assiut university heart hospital
City
Assiut
ZIP/Postal Code
2112
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kareem Ahmed Hosny, Bachelor of medicine
Phone
01000401994
Email
kareemdna94@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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