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

August 28, 2017 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bondy, France, 93140
        • Radiology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: extranodular "no touch" multipolar RFA
Procedure: Radiofrequency ablation
Percutaneous multipolar radiofrequency ablation.
Other Names:
  • radiofrequency extranodular or intanodular ablation
ACTIVE_COMPARATOR: intranodular multipolar RFA
Procedure: Radiofrequency ablation
Percutaneous multipolar radiofrequency ablation.
Other Names:
  • radiofrequency extranodular or intanodular ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
2 years global (local+distant) recurrence rate
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
2 years local recurrence rate
Time Frame: 2 years
2 years
2 years distant recurrence rate
Time Frame: 2 years
2 years
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Olivier Seror, professor, Radiology Department, CHU-Jean Verdier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 9, 2010

Primary Completion (ACTUAL)

October 6, 2016

Study Completion (ACTUAL)

October 6, 2016

Study Registration Dates

First Submitted

November 5, 2009

First Submitted That Met QC Criteria

November 5, 2009

First Posted (ESTIMATE)

November 6, 2009

Study Record Updates

Last Update Posted (ACTUAL)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P071213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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