Malignant Pleural EffusionNCT06964321
Effectiveness of Intercostal Tube Drainage Vs Pigtail Catheter Drainage Vs Ultrasound-Guided Aspiration in Management of Massive Malignant Pleural Effusion
A study testing intercostal tube drainage, big tail catheter drainage and ultrasound-guided aspiration in people with Malignant Pleural Effusion, run by Assiut University.
Trial summary
Pleural effusion is common in different diseases and especially malignant effusions can have fast onset symptoms such as chest pain, dyspnoea, and coughing. Malignant pleural effusion (MPE) is an exudative effusion with malignant cells. It is a common symptom and accompanying presentation of metastatic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Effusion
- What is being tested?
- intercostal tube drainage, big tail catheter drainage and ultrasound-guided aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult patient aged 18 years old and above.
- Patients diagnosed with massive malignant pleural effusion (MPE) requiring intervention.
Who cannot join
- Pediatric patients aged below 18 years
- Patients with non-malignant causes of pleural effusion.
About this study
Pleural effusion is common in different diseases and especially malignant effusions can have fast onset symptoms such as chest pain, dyspnoea, and coughing. Malignant pleural effusion (MPE) is an exudative effusion with malignant cells.
It is a common symptom and accompanying presentation of metastatic disease. It Impacts up to 15% of all patients with cancer and is the most common in breast, lung, cancer, lymphoma, and gynaecological malignancies . There are 150,000 new cases of MPE in the United States yearly and 100,000 in Europe . Patients have an overall survival (OS) rate of 3-12 months after the initial diagnosis . Malignant pleural effusion (MPE) poses significant challenges in management, impacting patient quality of life and overall prognosis. Almost all radiological procedures can help diagnose pleural effusions . Thoracentesis is used as a diagnostic and therapeutic tool. The procedure has been modified with the addition of ultrasound, that is very functional for targeting certain anatomical areas of the pleura and finding an appropriate entry point . Three primary strategies are commonly employed: intercostal tube drainage, big tail catheter drainage, and ultrasound-guided aspiration. This study aims to evaluate these methods' efficacy, safety, and outcomes. To compare intercostal tube drainage, big tail catheter drainage, and ultrasound-guided aspiration in managing massive malignant pleural effusion (MPE).
- Conditions
- Malignant Pleural Effusion
- Being tested
- intercostal tube drainage, big tail catheter drainage, ultrasound-guided aspiration
- 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.
intercostal tube drainageProcedure or surgery
intercostal tube drainage in managing massive malignant pleural effusion (MPE).
big tail catheter drainageProcedure or surgery
big tail catheter drainage in managing massive malignant pleural effusion (MPE).
ultrasound-guided aspirationProcedure or surgery
ultrasound-guided aspiration in managing massive malignant pleural effusion (MPE).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | intercostal tube drainage in managing massive malignant pleural effusion (MPE). Receives: Procedure: intercostal tube drainage |
| Group B | Active comparator | big tail catheter drainage in managing massive malignant pleural effusion (MPE). Receives: Procedure: big tail catheter drainage |
| Group C | Active comparator | ultrasound-guided aspiration in managing massive malignant pleural effusion (MPE). Receives: Procedure: ultrasound-guided aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of Pleural Effusion
Resolution of Pleural Effusion: Defined as complete or partial resolution based on imaging studies (e.g., chest X-ray or ultrasound).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (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
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Badrat William Mansour, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964321
- Sponsor's protocol ID
- IT drainage-pigtail-US Aspirat
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 9 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intercostal Tube Drainage Vs Pigtail Catheter Drainage Vs Ultrasound-Guided Aspiration in Management of Massive Malignant Pleural Effusion
- ClinicalTrials.gov ID
- NCT06964321
- Acronym / sponsor ID
- IT drainage-pigtail-US Aspirat
- Conditions
- Malignant Pleural Effusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 9 May 2025 (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.
Pleural effusion is common in different diseases and especially malignant effusions can have fast onset symptoms such as chest pain, dyspnoea, and coughing. Malignant pleural effusion (MPE) is an exudative effusion with malignant cells.
It is a common symptom and accompanying presentation of metastatic disease. It Impacts up to 15% of all patients with cancer and is the most common in breast, lung, cancer, lymphoma, and gynaecological malignancies . There are 150,000 new cases of MPE in the United States yearly and 100,000 in Europe . Patients have an overall survival (OS) rate of 3-12 months after the initial diagnosis . Malignant pleural effusion (MPE) poses significant challenges in management, impacting patient quality of life and overall prognosis. Almost all radiological procedures can help diagnose pleural effusions . Thoracentesis is used as a diagnostic and therapeutic tool. The procedure has been modified with the addition of ultrasound, that is very functional for targeting certain anatomical areas of the pleura and finding an appropriate entry point . Three primary strategies are commonly employed: intercostal tube drainage, big tail catheter drainage, and ultrasound-guided aspiration. This study aims to evaluate these methods' efficacy, safety, and outcomes. To compare intercostal tube drainage, big tail catheter drainage, and ultrasound-guided aspiration in managing massive malignant pleural effusion (MPE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: intercostal tube drainageintercostal tube drainage in managing massive malignant pleural effusion (MPE). |
| Group B | Active comparator | Procedure: big tail catheter drainagebig tail catheter drainage in managing massive malignant pleural effusion (MPE). |
| Group C | Active comparator | Procedure: ultrasound-guided aspirationultrasound-guided aspiration in managing massive malignant pleural effusion (MPE). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patient aged 18 years old and above.
- Patients diagnosed with massive malignant pleural effusion (MPE) requiring intervention.
Key exclusion criteria (2 listed)
- Pediatric patients aged below 18 years
- Patients with non-malignant causes of pleural effusion.
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 |
|---|---|---|
| intercostal tube drainageintercostal tube drainage in managing massive malignant pleural effusion (MPE). | Procedure or surgery | Group A |
| big tail catheter drainagebig tail catheter drainage in managing massive malignant pleural effusion (MPE). | Procedure or surgery | Group B |
| ultrasound-guided aspirationultrasound-guided aspiration in managing massive malignant pleural effusion (MPE). | Procedure or surgery | Group C |
Primary outcome
Resolution of Pleural Effusion
Time frame: baseline
Resolution of Pleural Effusion: Defined as complete or partial resolution based on imaging studies (e.g., chest X-ray or ultrasound).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing intercostal tube drainage, big tail catheter drainage and ultrasound-guided aspiration in people with Malignant Pleural Effusion, run by Assiut University.
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 2 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: opening soon, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Resolution of Pleural Effusion (time frame: baseline). 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 9 May 2025.