Malignant Pleural Effusion: Pleur-X vs. Chemical Pleurodesis in VATS
NCT ID: NCT03518788
Last Updated: 2018-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
234 participants
INTERVENTIONAL
2018-01-25
2020-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pleur-X
Placement of a permanent drainage under local anesthesia
Pleur-X
Permanent drainage
pleurodesis
Pleurodesis with talc in VATS
Pleurodesis
Pleurodesis with talc in permanent VATS
Interventions
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Pleur-X
Permanent drainage
Pleurodesis
Pleurodesis with talc in permanent VATS
Eligibility Criteria
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Inclusion Criteria
* First diagnosis of malignant pleural effusion
* Indication to treat the malignant pleural effusion with surgery
* Informed informed consent
Exclusion Criteria
* Pregnant women
* Trapped lung syndrome
* Patients with estimated life expectancy \< 4-8 weeks
18 Years
80 Years
ALL
No
Sponsors
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Clinical Trial Unit Ente Ospedaliero Cantonale
OTHER
Rolf Inderbitzi
OTHER
Responsible Party
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Rolf Inderbitzi
Head of thoracic surgery department
Principal Investigators
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Rolf Inderbitzi, MD
Role: STUDY_DIRECTOR
Ente Ospedaliero Cantonale, Bellinzona
Locations
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Ospedale San Giovanni
Bellinzona, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ORBV-CHIR-001
Identifier Type: -
Identifier Source: org_study_id
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