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Multicentre Prospective Clinical Trial for RFA Tumour Aspirator Treatment of Primary and Secondary Malignancies of the Liver

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2007 by University of Thessaly.
Recruitment status was:  Recruiting
Information provided by:
University of Thessaly Identifier:
First received: August 9, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
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

Condition Intervention Phase
Liver Cancer
Device: Hexablate
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre Prospective Clinical Trial of a New Bipolar Radiofrequency Ablation/Aspirator Device (Hexablate) in the Management of Primary and Secondary Liver Cancers

Resource links provided by NLM:

Further study details as provided by University of Thessaly:

Primary Outcome Measures:
  • To estimate the local and remote intra-hepatic and extra-hepatic recurrence rates and their impact on survival. [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Complications and unexpected adverse events (early and late) related to RFA aspirator treatment to be assessed. Data points to be collected as per proforma for trial. [ Time Frame: 2 years ]

Study Start Date: February 2007
Estimated Study Completion Date: August 2007
Detailed Description:

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.


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.


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.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00514930

Contact: Dimitris Zacharoulis, Assistant Professor +30-2410-682803
Contact: Nagy Habib, Professor of Surgery Tel: +44 (0) 20 83832033 / (0)

C. Hatzitheofilou Recruiting
Larisa, Greece, 41110
Contact: Dimitris Zacharoulis, Assistant Professor    +30-2410-682730 ext 2730   
Sub-Investigator: Ahmet Ayav, M.D.         
Sub-Investigator: Miroslav Millicevic, Professor         
Sub-Investigator: Riccardo Pellicci, M.D.         
Sponsors and Collaborators
University of Thessaly
Principal Investigator: Dimitris Zacharoulis, M.D. University of Thessaly
Study Chair: Nagy Habib, Professor Imperial College London U.K.
Study Director: Giuseppe Navarra, Professor University of Messina
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00514930     History of Changes
Other Study ID Numbers: Multicenter hexablate protocol
Study First Received: August 9, 2007
Last Updated: August 9, 2007

Keywords provided by University of Thessaly:
radiofrequency ablation
liver cancer
liver tumors

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on April 26, 2017