Malignant Pleural EffusionPleur-XNCT03518788
Malignant Pleural Effusion: Pleur-X vs. Chemical Pleurodesis in VATS
A study testing Pleur-X and Pleurodesis in people with Malignant Pleural Effusion, run by Rolf Inderbitzi at 1 site in Switzerland.
Trial summary
This is a prospective randomized study whose aim is to compare the efficacy of the permanent thoracic catheter (Pleur-X) versus chemical pleurodesis in videothoracoscopy (VATS) in the treatment of malignant pleural effusion at the first diagnosis.Patients with malignant pleural effusion for whom there is indication of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Pleural Effusion
- What is being tested?
- Pleur-X and Pleurodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Jan 2018to 31 Dec 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, <80 years
- First diagnosis of malignant pleural effusion
- Indication to treat the malignant pleural effusion with surgery
- Informed informed consent
Who cannot join
- Previous surgeries on the same hemitorace
- Pregnant women
- Trapped lung syndrome
- Patients with estimated life expectancy < 4-8 weeks
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Ospedale San Giovanni
Bellinzona, 6500
Rolf Inderbitzi, MD, +41 (0)91 811 91 76, rolf.inderbitzi@eoc.ch
Stefano Cafarotti, MD, +41 (0)91 811 93 40, stefano.cafarotti@eoc.ch
About this study
Official title: Randomized Clinical Trial to Evaluate the Efficacy of the Permanent Thoracic Catheter (Pleur-X) Towards Pleurodesis in Thoracoscopy in the Treatment of Malignant Pleural Effusion
This is a prospective randomized study whose aim is to compare the efficacy of the permanent thoracic catheter (Pleur-X) versus chemical pleurodesis in videothoracoscopy (VATS) in the treatment of malignant pleural effusion at the first diagnosis.Patients with malignant pleural effusion for whom there is indication of surgery and who agree to participate in the study will be randomized 1: 1 in the Pleur-X arm (arm 1) or in the chemical pleurodesis arm (arm 2).
The arm 1 provides for the installation of a permanent drainage under local anesthesia while the arm 2 provides a pleurodesis with talc in VATS under general anesthesia.
Both procedures are standard of care.
Read the detailed description
Before the study procedure the patients will be requested to perform some examination as physical and radiological examination. Patients will also complete questionnaires for quality of life assessment (EORTC QLQ 30) and symptoms (VAS for pain). Patients will then be randomized into one of the two arms.
For patients included in arm 1, a permanent drainage (Pleur-X) is provided under local anesthesia performed on an outpatient basis while for patients included in arm 2 a pleurodesis with talc in VATS is planned under general anesthesia. Arm 2 patients will be hospitalized for 5 days.
Patients will then be followed up to 3 months after surgery. During this period a medical examination will be required at 1 week, 4 weeks and 3 months after the intervention during which the patient will be asked to complete questionnaires for the evaluation of quality of life (EORTC QLQ 30) and symptoms (VAS for pain ). A chest radiograph will be performed after four weeks to evaluate the primary parameter. Adverse events will be collected throughout the study period.
- Conditions
- Malignant Pleural Effusion
- Being tested
- Pleur-X, Pleurodesis
- 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.
Pleur-XProcedure or surgery
Permanent drainage
PleurodesisProcedure or surgery
Pleurodesis with talc in permanent VATS
| Study group | Role | What they receive |
|---|---|---|
| Pleur-X | Experimental | Placement of a permanent drainage under local anesthesia Receives: Procedure: Pleur-X |
| pleurodesis | Experimental | Pleurodesis with talc in VATS Receives: Procedure: Pleurodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of the treatment with VPM
Evaluate the success rate of the treatment with VPM with radiological examination
Measured: 4 weeks
Secondary outcomes (3)
Adverse Event
Evaluate the tollerability of both procedures collecting adverse events
Measured: 3 months
Quality of live
quality of live will be determined with the evaluation of the EORTC QLQ 30 questionnaire
Measured: 3 months
Pain scale
Pain will be evaluated with the Visual Analogue Scale (VAS) where the score of 0 is no pain while the score 10 is very painfull
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 posted8 May 2018
- Study start25 Jan 2018
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Dec 2020 (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.
- 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
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rolf Inderbitzi
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit Ente Ospedaliero Cantonale
- Responsible party
- Sponsor-investigator, Rolf Inderbitzi, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Rolf Inderbitzi, MD, Study director, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518788
- Sponsor's protocol ID
- ORBV-CHIR-001
- Acronym
- Pleur-X
- Status last verified
- Apr 2018
- First submitted
- 6 Apr 2018
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Efficacy of the Permanent Thoracic Catheter (Pleur-X) Towards Pleurodesis in Thoracoscopy in the Treatment of Malignant Pleural Effusion
- ClinicalTrials.gov ID
- NCT03518788
- Acronym / sponsor ID
- Pleur-X / ORBV-CHIR-001
- Conditions
- Malignant Pleural Effusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Rolf InderbitziUniversity, hospital or other
- Collaborators
- Clinical Trial Unit Ente Ospedaliero Cantonale
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 8 May 2018 (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.
This is a prospective randomized study whose aim is to compare the efficacy of the permanent thoracic catheter (Pleur-X) versus chemical pleurodesis in videothoracoscopy (VATS) in the treatment of malignant pleural effusion at the first diagnosis.Patients with malignant pleural effusion for whom there is indication of surgery and who agree to participate in the study will be randomized 1: 1 in the Pleur-X arm (arm 1) or in the chemical pleurodesis arm (arm 2).
The arm 1 provides for the installation of a permanent drainage under local anesthesia while the arm 2 provides a pleurodesis with talc in VATS under general anesthesia.
Both procedures are standard of care.
Detailed description
Before the study procedure the patients will be requested to perform some examination as physical and radiological examination. Patients will also complete questionnaires for quality of life assessment (EORTC QLQ 30) and symptoms (VAS for pain). Patients will then be randomized into one of the two arms.
For patients included in arm 1, a permanent drainage (Pleur-X) is provided under local anesthesia performed on an outpatient basis while for patients included in arm 2 a pleurodesis with talc in VATS is planned under general anesthesia. Arm 2 patients will be hospitalized for 5 days.
Patients will then be followed up to 3 months after surgery. During this period a medical examination will be required at 1 week, 4 weeks and 3 months after the intervention during which the patient will be asked to complete questionnaires for the evaluation of quality of life (EORTC QLQ 30) and symptoms (VAS for pain ). A chest radiograph will be performed after four weeks to evaluate the primary parameter. Adverse events will be collected throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pleur-X | Experimental | Procedure: Pleur-XPlacement of a permanent drainage under local anesthesia |
| pleurodesis | Experimental | Procedure: PleurodesisPleurodesis with talc in VATS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years, <80 years
- First diagnosis of malignant pleural effusion
- Indication to treat the malignant pleural effusion with surgery
- Informed informed consent
Key exclusion criteria (4 listed)
- Previous surgeries on the same hemitorace
- Pregnant women
- Trapped lung syndrome
- Patients with estimated life expectancy < 4-8 weeks
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 |
|---|---|---|
| Pleur-XPermanent drainage | Procedure or surgery | Pleur-X |
| PleurodesisPleurodesis with talc in permanent VATS | Procedure or surgery | pleurodesis |
Primary outcome
Success rate of the treatment with VPM
Time frame: 4 weeks
Evaluate the success rate of the treatment with VPM with radiological examination
3 secondary outcomes
Adverse Event
Time frame: 3 months
Quality of live
Time frame: 3 months
Pain scale
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 8 May 2018.
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RecruitingObservational study
UNC Pleural Fluid Registry
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Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
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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.
Rolf Inderbitzi, MD study director
Ente Ospedaliero Cantonale, Bellinzona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pleur-X and Pleurodesis in people with Malignant Pleural Effusion, run by Rolf Inderbitzi at 1 site in Switzerland.
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 4 inclusion and 4 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 8 May 2018. 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 Switzerland. 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 Rolf Inderbitzi, MD (+41 (0)91 811 91 76, rolf.inderbitzi@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of the treatment with VPM (time frame: 4 weeks). 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 8 May 2018.