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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01008657
First received: November 5, 2009
Last updated: August 25, 2014
Last verified: August 2014

November 5, 2009
August 25, 2014
February 2010
March 2017   (final data collection date for primary outcome measure)
2 years global (local+distant) recurrence rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01008657 on ClinicalTrials.gov Archive Site
  • 2 years local recurrence rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 2 years distant recurrence rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Multipolar Radiofrequency Ablation for Hepatocellular Carcinoma Using Extra Nodular Versus Intranodular Technique
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

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.

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
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinomas
Procedure: Radiofrequency ablation
Percutaneous multipolar radiofrequency ablation.
Other Name: radiofrequency extranodular or intanodular ablation
  • Experimental: extranodular "no touch" multipolar RFA
    Intervention: Procedure: Radiofrequency ablation
  • Active Comparator: intranodular multipolar RFA
    Intervention: Procedure: Radiofrequency ablation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
216
March 2017
March 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01008657
P071213
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Olivier Seror, professor Radiology Department, CHU-Jean Verdier
Assistance Publique - Hôpitaux de Paris
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP