Clinical trial NCT01008657: Multipolar Radiofrequency Ablation for Hepatocellular Carcinoma Using Extra Nodular Versus Intranodular Technique
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinomas
Keywords: Radiofrequency-Extranodular-Multipolar ablation
Recurrence
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-11-06
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 2 years global (local+distant) recurrence rate
timeFrame: 2 years
Secondary outcomes:
measure: 2 years local recurrence rate
timeFrame: 2 years
measure: 2 years distant recurrence rate
timeFrame: 2 years
measure: Primary treatment effectiveness (assessed 1 month after completion of treatment course which can include up to 3 radiofrequency ablation (RFA) procedures performed monthly)
timeFrame: 2 years
Other outcomes:
Locations:
city: Bondy
country: France
facility: Radiology Department
Study officials:
affiliation: Radiology Department, CHU-Jean Verdier
name: Olivier Seror, professor
role: PRINCIPAL_INVESTIGATOR
References:
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