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

NCT ID: NCT06744946

Last Updated: 2024-12-20

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2024-12-04

Brief Summary

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

Detailed Description

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

Conditions

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Malignant Pleural Effusions (Mpe)- Pleurodesis Pleurodesis

Keywords

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Talc -pleurodesis-bleomycin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

thoracoscope

Intervention Type PROCEDURE

bleomycin- tranxemic acid mixture pleurodesis versus thoracoscopic talc poudrage

Interventions

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thoracoscope

bleomycin- tranxemic acid mixture pleurodesis versus thoracoscopic talc poudrage

Intervention Type PROCEDURE

Other Intervention Names

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intercostal tube

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role collaborator

Mohamed Sabry

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Sabry

Lecturer of chest diseases

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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mohamed sabry eltarhony, lecturer

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

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Chest Department -Faculty of Medicine

Alexandria, Azarita, Egypt

Site Status

Countries

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Egypt

Study Documents

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Document Type: Study Protocol

View Document

Related Links

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https://pubmed.ncbi.nlm.nih.gov/17482984/

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

Other Identifiers

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Talc Pleurodesis - Bleomycin

Identifier Type: -

Identifier Source: org_study_id