A Phase 1/2 interventional study of Hexablate in Liver Cancer, sponsored by University of Thessaly. Status unknown at 1 site in Greece. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2007-08-10.
Sponsored by University of Thessaly · Phase 1/2, Interventional, and Treatment
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
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.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
Browse Liver Neoplasms studies →University of Thessaly is the lead sponsor of 188 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
To estimate the local and remote intra-hepatic and extra-hepatic recurrence rates and their impact on survival.
Time frame: 2 years
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
This study is status unknown, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Thessaly