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 because the information has not been verified recently.
Verified August 2007 by University of Thessaly.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Thessaly
ClinicalTrials.gov Identifier:
NCT00514930
First received: August 9, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514930

Contacts
Contact: Dimitris Zacharoulis, Assistant Professor +30-2410-682803 zachadim@yahoo.com
Contact: Nagy Habib, Professor of Surgery Tel: +44 (0) 20 83832033 / (0) nagy.habib@imperial.ac.uk

Locations
Greece
C. Hatzitheofilou Recruiting
Larisa, Greece, 41110
Contact: Dimitris Zacharoulis, Assistant Professor    +30-2410-682730 ext 2730    zachadim@yahoo.com   
Sub-Investigator: Ahmet Ayav, M.D.         
Sub-Investigator: Miroslav Millicevic, Professor         
Sub-Investigator: Riccardo Pellicci, M.D.         
Sponsors and Collaborators
University of Thessaly
Investigators
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

No publications provided by University of Thessaly

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00514930     History of Changes
Other Study ID Numbers: Multicenter hexablate protocol
Study First Received: August 9, 2007
Last Updated: August 9, 2007
Health Authority: Greece: Ministry of Health and Welfare

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

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasm Metastasis
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on July 10, 2014