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

December 19, 2024 updated by: Mohamed Sabry

Comparison Between Pleurodesis by a Combination of Bleomycin and Tranxemic Acid Solution and Thoracoscopic Talc Poudrage in Malignant Pleural Effusion

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Closure of the space where the effusion is recurrently accumulated through talc poudrage in thoracoscopy or bleomycin - tranxemic acid solution injection in chest tube.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Azarita
      • Alexandria, Azarita, Egypt, 11521
        • Chest Department -Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- 1. Adult patients (more than 18 years) with malignant pleural effusion or highly suspected exudate.

2. Fit patients for the procedure selected.

Exclusion Criteria:

  1. Inability to provide informed consent for the procedure.
  2. Hemodynamically unstable patients.
  3. Bleeding diathesis.
  4. Uncontrolled cough.
  5. Hypoxic index less than 300.
  6. Endobronchial obstruction.
  7. Pleural thickening with trapped lung.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the first arm thoracoscopic talc poudrage and the second arm Bleomycin -Tranxemic mic acid mixture
the first arm is talc insufflation through medical thoracoscopy the second arm involve bleomycin- tranxemic acid mixture injection in intercostal tube
Procedure: thoracoscope
bleomycin- tranxemic acid mixture pleurodesis versus thoracoscopic talc poudrage
Other Names:
  • intercostal tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea Borg Scale
Time Frame: one month
the rate of shortness of breath from number 0 to number 10
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohamed Sabry

Collaborators

Alexandria University

Investigators

  • Principal Investigator: mohamed sabry eltarhony, lecturer, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

October 29, 2024

Study Completion (Actual)

December 4, 2024

Study Registration Dates

First Submitted

December 7, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 19, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Talc Pleurodesis - Bleomycin

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

because the facility, where i do my work, refuse to share any project untill it is fully published

Study Data/Documents

  1. Study Protocol
    Information identifier: msabry776@yahoo.com
    Information comments: very good

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pleurodesis

Clinical Trials on thoracoscope

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe