Multicentre Prospective Clinical Trial for RFA Tumour Aspirator Treatment of Primary and Secondary Malignancies of the Liver
NCT ID: NCT00514930
Last Updated: 2007-08-10
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
PHASE1/PHASE2
INTERVENTIONAL
2007-02-28
2007-08-31
Brief Summary
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Detailed Description
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This protocol is for a prospective multi-centre clinical trial of the use of RFA aspiration in the treatment of patients with primary/secondary malignancies of the liver, which are not suitable for formal liver resection. The basis for unresectability being the presence of extra-hepatic disease, limited liver synthetic function, co-morbidity (ASA\>3), bilobar disease and anatomical location. Early and late complications relating to the usage of the RFA aspirator will be analysed. Additionally, local recurrence and long term survival will be assessed. If the use of the RFA aspirator produces improved survival with minimal morbidity and mortality. Then these initial results will justify further in depth studies to establish its clinical role.
II. SPECIFIC AIMS/OBJECTIVES
The primary aim for this trial is to assess whether the RFA aspirator device is safe and of clinical benefit in patients with primary or secondary malignant liver tumours.
III. STUDY OVERVIEW
It is anticipated that 100-200 participants will be recruited. The time period for patient recruitment will be for 2 years with follow up for 3 years. The total study period will be 5 years in order to allow the assessment of complications, local ablation success and survival benefit.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Hexablate
Eligibility Criteria
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Inclusion Criteria
* Have unresectable primary/secondary malignant tumours of the liver. Unresectable criteria being the presence of extra-hepatic disease, limited liver synthetic function, co-morbidity (ASA 3), bilobar disease and anatomical location.
* Study specific signed informed consent will also have to be completed to allow patient inclusion.
Exclusion Criteria
* Pregnant women
* Uncorrectable coagulopathy
18 Years
85 Years
ALL
No
Sponsors
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University of Thessaly
OTHER
Principal Investigators
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Dimitris Zacharoulis, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Thessaly
Nagy Habib, Professor
Role: STUDY_CHAIR
Imperial College London U.K.
Giuseppe Navarra, Professor
Role: STUDY_DIRECTOR
University of Messina
Locations
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C. Hatzitheofilou
Larissa, , Greece
Countries
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Central Contacts
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Facility Contacts
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References
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Zacharoulis D, Khorsandi SE, Vavra P, Dostalik J, Navarra G, Nicholls JP, Jiao LR, Habib NA. Pilot study for a new bipolar radiofrequency ablation/aspirator device in the management of primary and secondary liver cancers. Liver Int. 2009 Jul;29(6):824-30. doi: 10.1111/j.1478-3231.2008.01910.x.
Other Identifiers
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Multicenter hexablate protocol
Identifier Type: -
Identifier Source: org_study_id