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

Liver Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00514930
• Other study ID #: Multicenter hexablate protocol
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: August 9, 2007
• Last updated: August 9, 2007
• Start date: February 2007
• Est. completion date: August 2007

Study information

• Verified date: August 2007
• Source: University of Thessaly
• Contact: Dimitris Zacharoulis, Assistant Professor
• Phone: +30-2410-682803
• Email: zachadim[@]yahoo.com
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: August 2007
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Device:
• Hexablate

Locations

Country	Name	City	State
Greece	C. Hatzitheofilou	Larisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the local and remote intra-hepatic and extra-hepatic recurrence rates and their impact on survival.		2 years
Secondary	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.		2 years