Thoracoscopic Talc Pleurodesis Versus Bleomycin -Tranxemi... | NCT06744946

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

NCT06744946

Sponsor

Mohamed Sabry

Status

Completed

Last Update Posted

Dec 20, 2024Actual

Enrollment

60Actual

Phase

Phase 4

Conditions

Malignant Pleural Effusions (Mpe)- Pleurodesis
Pleurodesis

Interventions

thoracoscope

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2024Actual

Primary Completion Date

Oct 29, 2024Actual

Completion Date

Dec 4, 2024Actual

First Submitted Date

Dec 7, 2024

First Submission Date that Met QC Criteria

Dec 19, 2024

First Posted Date

Dec 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2024

Last Update Posted Date

Dec 20, 2024Actual

Name	Class
Alexandria University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
thoracoscope	Procedure	bleomycin- tranxemic acid mixture pleurodesis versus thoracoscopic talc poudrage	the first arm thoracoscopic talc poudrage and the second arm Bleomycin -Tranxemic mic acid mixture

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
mohamed sabry eltarhony, lecturer	Alexandria University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chest Department -Faculty of Medicine		Alexandria	Azarita	11521	Egypt

References Module

Citations

Not provided

ID	Term
D010997	Pleural Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site

ID	Term
D019723	Endoscopes
D019719	Diagnostic Equipment
D004864	Equipment and Supplies
D013523	Surgical Equipment