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Trial Title:
Video Assisted Thoracoscopic Surgery (VATS) - Surgical Pleurodesis vs Tube Drainage in Management of Malignant Pleural Effusion (MPE)
NCT ID:
NCT05872126
Condition:
Malignant Pleural Effusion
Thoracic Cancer
Conditions: Official terms:
Pleural Effusion, Malignant
Pleural Effusion
Conditions: Keywords:
Malignant pleural effusion
VATS
PleurX
Abrasion
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
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 drainage
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
VATS-Surgical pleurodesis
Description:
VATS drainage and surgical abrasion.
Arm group label:
VATS surgical pleurodesis
Intervention type:
Procedure
Intervention name:
Tube Drainage
Description:
Tube drainage for malignant pleural effusion
Arm group label:
Tube drainage
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
Criteria for 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:
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.
Gender:
All
Minimum age:
5 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Assiut university heart hospital
Address:
City:
Assiut
Zip:
2112
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Kareem Ahmed Hosny, Bachelor of medicine
Phone:
01000401994
Email:
kareemdna94@gmail.com
Start date:
April 1, 2023
Completion date:
April 30, 2025
Lead sponsor:
Agency:
Assiut University
Agency class:
Other
Source:
Assiut University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05872126
