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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01008657
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : August 29, 2017
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinomas Procedure: Radiofrequency ablation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 9, 2010
Actual Primary Completion Date : October 6, 2016
Actual Study Completion Date : October 6, 2016

Arm Intervention/treatment
Experimental: extranodular "no touch" multipolar RFA Procedure: Radiofrequency ablation
Percutaneous multipolar radiofrequency ablation.
Other Name: radiofrequency extranodular or intanodular ablation

Active Comparator: intranodular multipolar RFA Procedure: Radiofrequency ablation
Percutaneous multipolar radiofrequency ablation.
Other Name: radiofrequency extranodular or intanodular ablation

Primary Outcome Measures :
  1. 2 years global (local+distant) recurrence rate [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 2 years local recurrence rate [ Time Frame: 2 years ]
  2. 2 years distant recurrence rate [ Time Frame: 2 years ]
  3. Primary treatment effectiveness (assessed 1 month after completion of treatment course which can include up to 3 radiofrequency ablation (RFA) procedures performed monthly) [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01008657

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Radiology Department
Bondy, France, 93140
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Olivier Seror, professor Radiology Department, CHU-Jean Verdier

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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01008657    
Other Study ID Numbers: P071213
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Radiofrequency-Extranodular-Multipolar ablation
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases