Multipolar Radiofrequency Ablation for Hepatocellular Carcinoma Using Extra Nodular Versus Intranodular Technique (ARMCENVIN)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Hepatocellular Carcinomas

Treatments

Procedure: Radiofrequency ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT01008657

P071213

Details and patient eligibility

About

The primary purpose of the trial is to demonstrate that at least a 40% drop of recurrence rate can be achieve in hepatocellular carcinoma patients treated with no touch multipolar radiofrequency ablation technique compared to those treated with usual intranodular multipolar technique.

Full description

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.

Enrollment

216 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults > 18 years old, holder of up to 3 nodules less than 4 cm in diameter
Diagnosis of hepatocellular carcinoma according to American Society of Liver Study non invasive criteria or based on histological proof
Non invasive diagnosis of cirrhosis according to French Haute Authority of illness guideline or based on histological proof
No previous treatment for hepatocellular carcinoma
Multidisciplinary decision of treatment by radiofrequency ablation

Exclusion criteria

Adult patient under guardianship or trusteeship, homeless
Patient with potentially short term life-threatening serious co-infection (apart from viral B or C, or VIH co-infection)
Pregnant or breastfeeding woman
Patient for whom regular follow-up is impossible whatever the cause
Contra indication to general anaesthesia
Technical impossibility to perform the procedure under ultrasound guidance
Boundary of the tumor located at less than 1 cm distance from colonic wall or main biliary tract (main right or left bill ducts and common bill duct)
Tumor invisible with ultrasound
Lack of safe percutaneous course which can be planned
Tumor in which more than four biopsies pass were previously performed (cumulated during one or several previous biopsies sessions)
Contra indication to perform CT or MRI with contrast medium (GADOLINITE or iodinate) intravenous injection
Child-Pugh B or C cirrhosis (apart from the transitory liver failures in the setting of acute hepatitis related to alcohol abuse)
Total detachment of the anterior face of the liver from internal abdominal wall due to abundant ascites.
Prothrombin activity < 50 %
Platelet count <40 .10 3/ml
Platelet dysfunction or congenital impaired blood coagulating