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

NCT05872126 | Unknown DMC

• 1 other identifier: AssiutMedicCTS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Malignant Pleural Effusion; Thoracic Cancer

Keywords

Malignant pleural effusion; VATS; PleurX; Abrasion

Outcome Measures

Primary Outcomes (2)

• Total hospital stay

  duration of hospital stay in days

  3 months postoperative

• duration of airleak

  duration in days

  3 months postoperative

Secondary Outcomes (3)

• Status of performance

  3 months

• mortality

  '3 months

• Failure of management

  3 months

Study Arms (2)

VATS surgical pleurodesis

OTHER

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

Procedure: VATS-Surgical pleurodesis

Tube drainage

OTHER

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

Procedure: Tube Drainage

Interventions

VATS-Surgical pleurodesis PROCEDURE

VATS drainage and surgical abrasion.

VATS surgical pleurodesis

Tube Drainage PROCEDURE

Tube drainage for malignant pleural effusion

Tube drainage

Eligibility Criteria

• Age: 5 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with symptomatic malignant pleural effusion. 2- symptomatic patients with shortness of breath. 3-Lung can be fully expanded.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university heart hospital

Asyut, 2112, Egypt

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Central Study Contacts

Kareem A Hosny, M.SC

CONTACT

01000401994; kareemdna94@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Randomised Clinical Trial with 2 groups; Case group for VATS mechanical abrasion and Control group for tube drainage

Study Record Dates

• First Submitted: May 13, 2023
• First Posted: May 24, 2023
• Study Start: April 1, 2023
• Primary Completion: March 31, 2025
• Study Completion: April 30, 2025
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

EG (1)