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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01008657
First received: November 5, 2009
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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 Intervention
Hepatocellular Carcinomas
Procedure: Radiofrequency ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 2 years global (local+distant) recurrence rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 216
Study Start Date: February 2010
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01008657

Contacts
Contact: Olivier Seror, professor 01 48 02 50 77 olivier.seror@jvr.aphp.fr

Locations
France
Radiology Department Recruiting
Bondy, France, 93140
Contact: Olivier Seror, professor    Tel : 01 48 02 50 77    olivier.seror@jvr.aphp.fr   
Principal Investigator: Olivier Seror, professor         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Olivier Seror, professor Radiology Department, CHU-Jean Verdier
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01008657     History of Changes
Other Study ID Numbers: P071213
Study First Received: November 5, 2009
Last Updated: November 14, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Radiofrequency-Extranodular-Multipolar ablation
Recurrence

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 23, 2014