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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinomas

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

2 years global (local+distant) recurrence rate

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Olivier Seror, professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radiology Department, CHU-Jean Verdier

Authority:

France: Ministry of Health

Study ID:

P071213

NCT ID:

NCT01008657

Start Date:

February 2009

Completion Date:

August 2015

Related Keywords:

  • Hepatocellular Carcinomas
  • Radiofrequency-Extranodular-Multipolar ablation
  • Recurrence
  • Carcinoma
  • Carcinoma, Hepatocellular

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