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
20 participants
INTERVENTIONAL
2017-04-21
2018-02-15
Brief Summary
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The aim of this study is to obtain pilot data - comparing patients receiving two different types of indwelling pleural catethers normally used in clinical practice (10 patients receiving Pleurocath® and 10 patients receiving PleurX®) - for power calculation of a Randomized Controlled Trial comparing two different drainages for MPE trapped lung.
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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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PleurX
Positioning of Pleurx drainage during surgical exploration if lung does not reinflate
PleurX
Positioning of drainage PleurX
Pleurocath
Positioning of Pleur o cath drainage during surgical exploration if lung does not reinflate
Pleurocath
Positioning of drainage Pleurocath
Interventions
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PleurX
Positioning of drainage PleurX
Pleurocath
Positioning of drainage Pleurocath
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Expected survival of less than 3 months
* Chylothorax
* Total white blood cell count less than 1000/microL
* Pregnancy or lactating mothers
* Irreversible bleeding diathesis
* Irreversible visual impairment
* Contraindications to general anesthesia
* Poor general clinical conditions ( ECOG PS \>=2)
* Patients unable to provide informed consent
18 Years
ALL
No
Sponsors
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European Institute of Oncology
OTHER
Responsible Party
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Principal Investigators
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Francesco Petrella, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
European Institute of Oncology
Locations
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European Institute of Oncology
Milan, , Italy
Countries
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Other Identifiers
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R 574/17 - IEO 607
Identifier Type: -
Identifier Source: org_study_id
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