Safety of InterventionNCT01409551
Video-assisted Hyperthermic Pleural Chemoperfusion vs Talc Pleurodesis for Refractory Malignant Pleural Effusions.
A study testing VATS hyperthermic chemoperfusion and Bedside talc slurry pleurodesis in people with Safety of Intervention and Efficacy of Intervention, run by Theagenio Cancer Hospital at 1 site in Greece.
Trial summary
Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural effusions, in terms of safety and efficacy. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Safety of Intervention, Efficacy of Intervention, Cost Effectiveness
- What is being tested?
- VATS hyperthermic chemoperfusion and Bedside talc slurry pleurodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- Aug 2011to Nov 2014
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Recurrent symptomatic malignant pleural effusion
- No prior intrapleural therapy
- Abscence of bronchial obstruction or fibrosis preventing lung reexpansion
- No systemic chemotherapy immediately prior to or during the first 30-day interval following pleurodesis
Who cannot join
- Poor Karnofsky Performance Status
Trial locations and contacts
1 site in 1 country.
Greece1 site
Thoracic Surgery Department, Theagenio Cancer Hospital
Thessaloniki, 54007
About this study
Official title: Video-assisted Hyperthermic Pleural Chemoperfusion Versus Bed-side Talc Slurry Pleurodesis for Refractory Malignant Pleural Effusions.
Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural effusions, in terms of safety and efficacy.
Read the detailed description
The study compares prospectively two groups of patients with refractory maignant pleural effusion. Group A consists of patients undergoing video-assisted hyperthermic pleural chemoperfusion (with a pump machine) and group B includes patients undergoing bed-side tube thoracostomy and talc slurry pleurodesis.
- Being tested
- VATS hyperthermic chemoperfusion, Bedside talc slurry pleurodesis
- Keywords
- Pleural effusion, VATS, hyperthermia, thoracostomy, pleurodesis
- Medical subject headings
- Pleural Effusion, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VATS hyperthermic chemoperfusionProcedure or surgery
VATS, adhesiolysis, hyperthermic chemoperfusion (with a pump machine)
Bedside talc slurry pleurodesisProcedure or surgery
Bedside tube thoracostomy under local anesthesia. Bedside talc slurry pleurodesis.
| Study group | Role | What they receive |
|---|---|---|
| VATS hyperthermic pleural chemoperfusion | Active comparator | The patients undergo a VATS drainage of pleural effusion with adhesiolysis and complete mobilization of the lung, following by a 1 hour hyperthermic (40oC)chemoperfusion by means of a pump machine. Receives: Procedure: VATS hyperthermic chemoperfusion |
| Bedside talc slurry pleurodesis | Active comparator | The patients undergo tube thoracostomy under local anesthesia. When the lung is fully expanded, talc slurry bed-side pleurodesis is performed. Receives: Procedure: Bedside talc slurry pleurodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of pleural effusion
Measured: 2 months following intervention
Secondary outcomes (1)
Morbidity
Measured: Postoperative period (7 days following intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety of InterventionStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theagenio Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nikolaos Barbetakis, Theagenio Cancer Hospital
- Investigators
- Nikolaos Barbetakis, MD, PhD, Principal investigator, Theagenio Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409551
- Sponsor's protocol ID
- Theagenio Thoracic Surgery 2
- Status last verified
- Nov 2014
- First submitted
- 3 Aug 2011
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-assisted Hyperthermic Pleural Chemoperfusion Versus Bed-side Talc Slurry Pleurodesis for Refractory Malignant Pleural Effusions.
- ClinicalTrials.gov ID
- NCT01409551
- Acronym / sponsor ID
- Theagenio Thoracic Surgery 2
- Keywords
- Pleural effusion, VATS, hyperthermia, thoracostomy, pleurodesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Theagenio Cancer HospitalOther government
- Study start
- Aug 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 4 Aug 2011 (estimated)
- 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.
Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural effusions, in terms of safety and efficacy.
Detailed description
The study compares prospectively two groups of patients with refractory maignant pleural effusion. Group A consists of patients undergoing video-assisted hyperthermic pleural chemoperfusion (with a pump machine) and group B includes patients undergoing bed-side tube thoracostomy and talc slurry pleurodesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VATS hyperthermic pleural chemoperfusion | Active comparator | Procedure: VATS hyperthermic chemoperfusionThe patients undergo a VATS drainage of pleural effusion with adhesiolysis and complete mobilization of the lung, following by a 1 hour hyperthermic (40oC)chemoperfusion by means of a pump machine. |
| Bedside talc slurry pleurodesis | Active comparator | Procedure: Bedside talc slurry pleurodesisThe patients undergo tube thoracostomy under local anesthesia. When the lung is fully expanded, talc slurry bed-side pleurodesis is performed. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Recurrent symptomatic malignant pleural effusion
- No prior intrapleural therapy
- Abscence of bronchial obstruction or fibrosis preventing lung reexpansion
- No systemic chemotherapy immediately prior to or during the first 30-day interval following pleurodesis
Key exclusion criteria (1 listed)
- Poor Karnofsky Performance Status
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 hyperthermic chemoperfusionVATS, adhesiolysis, hyperthermic chemoperfusion (with a pump machine) | Procedure or surgery | VATS hyperthermic pleural chemoperfusion |
| Bedside talc slurry pleurodesisBedside tube thoracostomy under local anesthesia. Bedside talc slurry pleurodesis. | Procedure or surgery | Bedside talc slurry pleurodesis |
Primary outcome
Recurrence of pleural effusion
Time frame: 2 months following intervention
1 secondary outcome
Morbidity
Time frame: Postoperative period (7 days following intervention)
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 17 Nov 2014.
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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.
Nikolaos Barbetakis, MD, PhD principal investigator
Theagenio Cancer Hospital
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 hyperthermic chemoperfusion and Bedside talc slurry pleurodesis in people with Safety of Intervention and Efficacy of Intervention, run by Theagenio Cancer Hospital at 1 site in Greece.
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 1 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 17 Nov 2014. 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 Greece. 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?
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?
Recurrence of pleural effusion (time frame: 2 months following intervention). 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 17 Nov 2014.