Malignant Pleural EffusionNCT05872126
Video Assisted Thoracoscopic Surgery (VATS) - Surgical Pleurodesis vs Tube Drainage in Management of Malignant Pleural Effusion (MPE)
A study testing VATS-Surgical pleurodesis and Tube Drainage in people with Malignant Pleural Effusion and Thoracic Cancer, run by Assiut University at 1 site in Egypt.
Trial summary
Malignant Pleural Effusion (MPE) is considered to be a common presentation at malignant tumors representing 15% of all cancer cases. It carries a burden on our patients with dyspnea being the most common symptom in most of cases. Management of symptomatic malignant pleural effusion remains to be a point of debate. Read more about this study
- Who is it for?
- Ages 5 to 90 years
- Conditions the study is for
- Malignant Pleural Effusion, Thoracic Cancer
- What is being tested?
- VATS-Surgical pleurodesis and Tube Drainage
- Type of treatment
- 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 Apr 2023to 30 Apr 2025
- Phase
- Interventional
- 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 5 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1-patients with symptomatic malignant pleural effusion. 2- symptomatic patients with shortness of breath. 3-Lung can be fully expanded.
Who cannot join
- Patients with non symptomatic malignant pleural effusion
- Pleural symphysis with no potentiality for re-expansion
- Patients managed surgically through open thoracotomy.
- Pleural effusion due to causes other than malignancy
- Loculated malignant effusion judged by chest ultrasound
- Trapped lung due to malignant pleural effusion assessed by multislice CT chest.,
- .Refusal to share the research project and not to sign the consent.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university heart hospital
Asyut, 2112
Kareem Ahmed Hosny, Bachelor of medicine, 01000401994, kareemdna94@gmail.com
About this study
Malignant Pleural Effusion (MPE) is considered to be a common presentation at malignant tumors representing 15% of all cancer cases. It carries a burden on our patients with dyspnea being the most common symptom in most of cases.
Management of symptomatic malignant pleural effusion remains to be a point of debate. Data available from literature shows conflicting results lacking high quality evidence which necsscitates further research work. Options differs to include chemical pleurodesis using medical or surgical talc poudrage or slurry. Surgical intervention with abrasion pleurodesis or pleurectomy using VATS approach has been used in many studies. Using indwelling pleural catheters (IPCs) has also proved comparable efficacy at many clinical trials. In this study we want to help answering this question so that we can add to the current knowledge aiming to offer the best care for those patients
- Conditions
- Malignant Pleural Effusion, Thoracic Cancer
- Being tested
- VATS-Surgical pleurodesis, Tube Drainage
- Keywords
- Malignant pleural effusion, VATS, PleurX, Abrasion
- 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.
VATS-Surgical pleurodesisProcedure or surgery
VATS drainage and surgical abrasion.
Tube DrainageProcedure or surgery
Tube drainage for malignant pleural effusion
| Study group | Role | What they receive |
|---|---|---|
| VATS surgical pleurodesis | Other | Patients in whom we use VATS-surgical pleurodesis for malignant pleural effusion. Receives: Procedure: VATS-Surgical pleurodesis |
| Tube drainage | Other | Patients in whom we use tube drainage for malignant pleural effusion. Receives: Procedure: Tube Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total hospital stay
duration of hospital stay in days
Measured: 3 months postoperative
duration of airleak
duration in days
Measured: 3 months postoperative
Secondary outcomes (3)
Status of performance
patient reported outcome through a pre-prepared questionnaire
Measured: 3 months
mortality
Rate of mortality
Measured: '3 months
Failure of management
time to re-collection
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Apr 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Clinical Trial with 2 groups; Case group for VATS mechanical abrasion and Control group for tube drainage
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem Ahmed Hosny, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872126
- Sponsor's protocol ID
- AssiutMedicCTS
- Status last verified
- May 2023
- First submitted
- 13 May 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Assisted Thoracoscopic Surgery (VATS) - Surgical Pleurodesis vs Tube Drainage in Management of Malignant Pleural Effusion (MPE)
- ClinicalTrials.gov ID
- NCT05872126
- Acronym / sponsor ID
- AssiutMedicCTS
- Conditions
- Malignant Pleural Effusion, Thoracic Cancer
- Keywords
- Malignant pleural effusion, VATS, PleurX, Abrasion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 24 May 2023 (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.
Malignant Pleural Effusion (MPE) is considered to be a common presentation at malignant tumors representing 15% of all cancer cases. It carries a burden on our patients with dyspnea being the most common symptom in most of cases.
Management of symptomatic malignant pleural effusion remains to be a point of debate. Data available from literature shows conflicting results lacking high quality evidence which necsscitates further research work. Options differs to include chemical pleurodesis using medical or surgical talc poudrage or slurry. Surgical intervention with abrasion pleurodesis or pleurectomy using VATS approach has been used in many studies. Using indwelling pleural catheters (IPCs) has also proved comparable efficacy at many clinical trials. In this study we want to help answering this question so that we can add to the current knowledge aiming to offer the best care for those patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Clinical Trial with 2 groups; Case group for VATS mechanical abrasion and Control group for tube drainage
| Arm | Type | Receives |
|---|---|---|
| VATS surgical pleurodesis | Other | Procedure: VATS-Surgical pleurodesisPatients in whom we use VATS-surgical pleurodesis for malignant pleural effusion. |
| Tube drainage | Other | Procedure: Tube DrainagePatients in whom we use tube drainage for malignant pleural effusion. |
Who may qualify
- Ages
- 5 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1-patients with symptomatic malignant pleural effusion. 2- symptomatic patients with shortness of breath. 3-Lung can be fully expanded.
Key exclusion criteria (7 listed)
- Patients with non symptomatic malignant pleural effusion
- Pleural symphysis with no potentiality for re-expansion
- Patients managed surgically through open thoracotomy.
- Pleural effusion due to causes other than malignancy
- Loculated malignant effusion judged by chest ultrasound
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 |
|---|---|---|
| VATS-Surgical pleurodesisVATS drainage and surgical abrasion. | Procedure or surgery | VATS surgical pleurodesis |
| Tube DrainageTube drainage for malignant pleural effusion | Procedure or surgery | Tube drainage |
Primary outcome
Total hospital stay
Time frame: 3 months postoperative
duration of hospital stay in days
duration of airleak
Time frame: 3 months postoperative
duration in days
3 secondary outcomes
Status of performance
Time frame: 3 months
mortality
Time frame: '3 months
Failure of management
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VATS-Surgical pleurodesis and Tube Drainage in people with Malignant Pleural Effusion and Thoracic Cancer, run by Assiut University 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 1 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: status not confirmed, as of the sponsor's last update on 24 May 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kareem A Hosny, M.SC (01000401994, kareemdna94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total hospital stay (time frame: 3 months postoperative). The study lists 2 primary outcomes in all. 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 24 May 2023.