Malignant Pleural Effusions (Mpe)- PleurodesisPhase 4NCT06744946
Thoracoscopic Talc Pleurodesis Versus Bleomycin -Tranxemic Acid Mixture Injection in Chest Tube in Malignant Pleural Effusion
A Phase 4 study testing thoracoscope in people with Malignant Pleural Effusions (Mpe)- Pleurodesis and Pleurodesis, run by Mohamed Sabry at 1 site in Egypt.
Trial summary
Comparing Two Methods to Treat Fluid Build-up in Chest for Cancer Patients:Talc Powder Surgery versus Chest Tube Medicine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Effusions (Mpe)- Pleurodesis, Pleurodesis
- What is being tested?
- thoracoscope
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 4 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adult patients (more than 18 years) with malignant pleural effusion or highly suspected exudate.
- 2. Fit patients for the procedure selected.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- thoracoscope
- Keywords
- Talc -pleurodesis-bleomycin
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracoscopeProcedure or surgery
Also called intercostal tube
bleomycin- tranxemic acid mixture pleurodesis versus thoracoscopic talc poudrage
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: thoracoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea Borg Scale
the rate of shortness of breath from number 0 to number 10
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Sep 2024
- Primary completion29 Oct 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural Effusions (Mpe)- PleurodesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Sabry
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Mohamed Sabry, Alexandria University
- Investigators
- mohamed sabry eltarhony, lecturer, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744946
- Sponsor's protocol ID
- Talc Pleurodesis - Bleomycin
- Status last verified
- Dec 2024
- First submitted
- 7 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: because the facility, where i do my work, refuse to share any project untill it is fully published
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Pleurodesis by a Combination of Bleomycin and Tranxemic Acid Solution and Thoracoscopic Talc Poudrage in Malignant Pleural Effusion
- ClinicalTrials.gov ID
- NCT06744946
- Acronym / sponsor ID
- Talc Pleurodesis - Bleomycin
- Keywords
- Talc -pleurodesis-bleomycin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mohamed SabryUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| the first arm thoracoscopic talc poudrage and the second arm Bleomycin -Tranxemic mic acid mixture | Experimental | Procedure: thoracoscopethe first arm is talc insufflation through medical thoracoscopy the second arm involve bleomycin- tranxemic acid mixture injection in intercostal tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Adult patients (more than 18 years) with malignant pleural effusion or highly suspected exudate.
- 2. Fit patients for the procedure selected.
Key exclusion criteria (7 listed)
- Inability to provide informed consent for the procedure.
- Hemodynamically unstable patients.
- Bleeding diathesis.
- Uncontrolled cough.
- Hypoxic index less than 300.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thoracoscopeAlso: intercostal tubebleomycin- tranxemic acid mixture pleurodesis versus thoracoscopic talc poudrage | Procedure or surgery | the first arm thoracoscopic talc poudrage and the second arm Bleomycin -Tranxemic mic acid mixture |
Primary outcome
Dyspnea Borg Scale
Time frame: one month
the rate of shortness of breath from number 0 to number 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Safety of pleurodesis with talc poudrage in malignant pleural effusion: a prospective cohort study. Lancet . 2007 May 5;369(9572):1535-1539Link provided by the sponsor.
- Individual participant dataSharing planned: No. because the facility, where i do my work, refuse to share any project untill it is fully published
Related trials for Malignant Pleural Effusions (Mpe)- Pleurodesis
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion
Not yet recruitingPhase 2
Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion
Lung Cancer (NSCLC), Malignant Pleural Effusions (Mpe)- Pleurodesis
Not yet recruitingEarly Phase 1
The Outcome of Inserting Intercostal Tube or Pleurodesis for Malignant Pleural Effusion
Malignant Pleural Effusions (Mpe)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mohamed sabry eltarhony, lecturer principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing thoracoscope in people with Malignant Pleural Effusions (Mpe)- Pleurodesis and Pleurodesis, run by Mohamed Sabry at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea Borg Scale (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.