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A Multicentre Prospective Clinical Trial of a New Bipolar Radiofrequency Ablation/Aspirator Device (Hexablate) in the Management of Primary and Secondary Liver Cancers


Phase 1/Phase 2
18 Years
85 Years
Open (Enrolling)
Both
Liver Cancer

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Trial Information

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
benefit.


Inclusion Criteria:



- Eligible participants will be 18 years and older.

- 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:

- Age younger than 18 years old

- Pregnant women

- Uncorrectable coagulopathy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate the local and remote intra-hepatic and extra-hepatic recurrence rates and their impact on survival.

Outcome Time Frame:

2 years

Principal Investigator

Dimitris Zacharoulis, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Thessaly

Authority:

Greece: Ministry of Health and Welfare

Study ID:

Multicenter hexablate protocol

NCT ID:

NCT00514930

Start Date:

February 2007

Completion Date:

August 2007

Related Keywords:

  • Liver Cancer
  • radiofrequency ablation
  • liver cancer
  • complications
  • liver tumors
  • Liver Neoplasms
  • Neoplasm Metastasis

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