Multipolar Radiofrequency Ablation for the Treatment of Hepatocellular Carcinoma Using Classical Intranodular Technique Versus Extra Nodular Technique So-called "No Touch" Technique: A Prospective Randomized Trial
206 patients with hepatocellular carcinoma(s) including up to three nodules measuring up to
four cm in diameter, will be randomized in two therapeutic legs: multipolar no touch
radiofrequency versus multipolar intra nodular radiofrequency. Patients previously treated
for hepatocellular carcinoma will not be enrolled in the study. Diagnostic of hepatocellular
carcinoma will be based on American Society of Liver Diseases guide line. Early response to
the treatment will be assessed one month after the radiofrequency ablation procedures (up to
three in case of incomplete necrosis) with dynamic contrast medium enhanced CT or MRI liver
examinations. For the follow up dynamic contrast medium enhanced CT or MRI liver
examinations will be performed every three months.
The trial will last for 73 months including 45 months for the recruitment of patients. The
main criteria of judgement will be the 2-years recurrence rate.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
2 years global (local+distant) recurrence rate
2 years
Yes
Olivier Seror, professor
Principal Investigator
Radiology Department, CHU-Jean Verdier
France: Ministry of Health
P071213
NCT01008657
February 2009
August 2015
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