Video-assisted Hyperthermic Pleural Chemoperfusion vs Talc Pleurodesis for Refractory Malignant Pleural Effusions.
NCT ID: NCT01409551
Last Updated: 2014-11-17
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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COMPLETED
NA
60 participants
INTERVENTIONAL
2011-08-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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VATS hyperthermic pleural chemoperfusion
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.
VATS hyperthermic chemoperfusion
VATS, adhesiolysis, hyperthermic chemoperfusion (with a pump machine)
Bedside talc slurry pleurodesis
The patients undergo tube thoracostomy under local anesthesia. When the lung is fully expanded, talc slurry bed-side pleurodesis is performed.
Bedside talc slurry pleurodesis
Bedside tube thoracostomy under local anesthesia. Bedside talc slurry pleurodesis.
Interventions
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VATS hyperthermic chemoperfusion
VATS, adhesiolysis, hyperthermic chemoperfusion (with a pump machine)
Bedside talc slurry pleurodesis
Bedside tube thoracostomy under local anesthesia. Bedside talc slurry pleurodesis.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
75 Years
ALL
No
Sponsors
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Theagenio Cancer Hospital
OTHER_GOV
Responsible Party
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Nikolaos Barbetakis
Head of Thoracic Surgery Department
Principal Investigators
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Nikolaos Barbetakis, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Theagenio Cancer Hospital
Locations
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Thoracic Surgery Department, Theagenio Cancer Hospital
Thessaloniki, , Greece
Countries
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Other Identifiers
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Theagenio Thoracic Surgery 2
Identifier Type: -
Identifier Source: org_study_id