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

NCT ID: NCT05872126

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-04-30

Brief Summary

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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

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Conditions

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Malignant Pleural Effusion Thoracic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised Clinical Trial with 2 groups; Case group for VATS mechanical abrasion and Control group for tube drainage
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VATS surgical pleurodesis

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

Group Type OTHER

VATS-Surgical pleurodesis

Intervention Type PROCEDURE

VATS drainage and surgical abrasion.

Tube drainage

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

Group Type OTHER

Tube Drainage

Intervention Type PROCEDURE

Tube drainage for malignant pleural effusion

Interventions

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VATS-Surgical pleurodesis

VATS drainage and surgical abrasion.

Intervention Type PROCEDURE

Tube Drainage

Tube drainage for malignant pleural effusion

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Kareem Ahmed Hosny

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut university heart hospital

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Kareem A Hosny, M.SC

Role: CONTACT

01000401994

Facility Contacts

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Kareem Ahmed Hosny, Bachelor of medicine

Role: primary

01000401994

Other Identifiers

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AssiutMedicCTS

Identifier Type: -

Identifier Source: org_study_id

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