A Multicentre Prospective Clinical Trial of a New Bipolar Radiofrequency Ablation/Aspirator Device (Hexablate) in the Management of Primary and Secondary Liver Cancers
Patients with unresectable primary or secondary malignancies of the liver have limited
treatment options which often only give a small survival benefit. RFA has been demonstrated
to be effective in local tumour eradication and to extend patient survival. In this study
RFA aspiration will be used to treat unresectable primary or secondary tumours of the liver.
RFA will be used to develop a shell of tissue destruction around the tumour, with aspiration
removing tissue and fluid from the centre of the lesion. The potential advantages of
aspirating during ablation could be to reduce aerosol spread of tumour within the liver
parenchyma and peritoneum. Additionally, aspirating the ablated tissue may reduce the
incidence of systemic side effects related to RFA when larger lesions are treated. This
study would establish the safety and efficiacy of RFA aspiration in the treatment of
unresectable primary/secondary malignancies of the liver.
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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To estimate the local and remote intra-hepatic and extra-hepatic recurrence rates and their impact on survival.
Dimitris Zacharoulis, M.D.
University of Thessaly
Greece: Ministry of Health and Welfare
Multicenter hexablate protocol