Thoracoscopic Talc Pleurodesis Versus Bleomycin -Tranxemic Acid Mixture Injection in Chest Tube in Malignant Pleural Effusion

NCT06744946 | Completed Phase 4 DMC

• 1 other identifier: Talc Pleurodesis - Bleomycin
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Comparing Two Methods to Treat Fluid Build-up in Chest for Cancer Patients:Talc Powder Surgery versus Chest Tube Medicine.

Conditions

Malignant Pleural Effusions (Mpe)- Pleurodesis; Pleurodesis

Keywords

Talc -pleurodesis-bleomycin

Outcome Measures

Primary Outcomes (1)

• Dyspnea Borg Scale

  the rate of shortness of breath from number 0 to number 10

  one month

Study Arms (1)

the first arm thoracoscopic talc poudrage and the second arm Bleomycin -Tranxemic mic acid mixture

EXPERIMENTAL

the first arm is talc insufflation through medical thoracoscopy the second arm involve bleomycin- tranxemic acid mixture injection in intercostal tube

Procedure: thoracoscope

Interventions

thoracoscope PROCEDURE

bleomycin- tranxemic acid mixture pleurodesis versus thoracoscopic talc poudrage

Also known as: intercostal tube

the first arm thoracoscopic talc poudrage and the second arm Bleomycin -Tranxemic mic acid mixture

Eligibility Criteria

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

You may qualify if:

• \- 1. Adult patients (more than 18 years) with malignant pleural effusion or highly suspected exudate.
• \. Fit patients for the procedure selected.

You may not qualify if:

• Inability to provide informed consent for the procedure.
• Hemodynamically unstable patients.
• Bleeding diathesis.
• Uncontrolled cough.
• Hypoxic index less than 300.
• Endobronchial obstruction.
• Pleural thickening with trapped lung.

Sponsors & Collaborators

• Mohamed Sabry: lead
• Alexandria University: collaborator

Study Sites (1)

Chest Department -Faculty of Medicine

Alexandria, Azarita, 11521, Egypt

Location

Related Links

• Safety of pleurodesis with talc poudrage in malignant pleural effusion: a prospective cohort study. Lancet . 2007 May 5;369(9572):1535-1539

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

Thoracoscopes

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Study Officials

• mohamed sabry eltarhony, lecturer

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of chest diseases

Model Details: comparing between two groups of thirty patients each,the first group will include talc poudrage pleurodesis and the second include chest tube injection of a mixture of bleomycin and tranxemic acid

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: December 20, 2024
• Study Start: September 1, 2024
• Primary Completion: October 29, 2024
• Study Completion: December 4, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)