Comparison Between Radiofrequency Versus Ethanol Injection for the Treatment of Hepatocellular Carcinoma

July 21, 2006 updated by: Azienda Ospedaliera San Giovanni Battista

Comparative Study Between Radiofrequency and Ethanol Injection for the Ablation of Small Hepatocellular Carcinoma Associated With Liver Cirrhosis

Ethanol injection has been for many years the standard approach as percutaneous treatment of non-surgical early hepatocellular carcinoma in cirrhotic patients. Radiofrequency ablation has been proposed as an alternative approach and some retrospective and prospective comparative trials indicated its better performance for the local control of the disease in comparison to ethanol injection. Some prospective randomized studies from Japan and from Taiwan reported also an increase of overall survival in the patients treated by Radiofrequency. Aim of this study is to compare the two techniques in a prospective randomized trial in western patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Currently early hepatocellular carcinoma (HCC) complicating liver cirrhosis is often treated by percutaneous ablation techniques under ultrasound guidance: their performance is easy, safe and efficient. They are less invasive and expensive than surgical removal, representing a potential local cure for a larger number of patients than those who could be treated by a liver resection or offered a liver transplantation.

Percutaneous ethanol injection (PEI), the first non-surgical technique introduced in clinical practice, has been widely used since the late eighties. PEI induces a chemical and ischemic coagulative necrosis in 70-80% of small (<3cm) HCC lesions. Necrosis obtained by this way is generally restricted to the neoplastic lesion itself; the chemical ablation may be moreover hampered by internal scars, that limit the uniform spreading of ethanol and by possible uncontrolled flows outside the lesion, with the ultimate result of a reduced necrotic effect and persistence of residual vital nests of neoplasia in as many as 33% of the cases. Nevertheless, the survival after PEI seems not different from surgery in retrospective series and this technique was indicated as the standard percutaneous treatment for early HCC in the 2001 guidelines of the European Association for the Study of the Liver (EASL).

In 1993 radio-frequency ablation (RF) was proposed as a new technique for the ablation of small HCCs. RF induces heat-generated coagulative necrosis of the neoplastic lesion and surrounding liver tissue. However, RF is not suitable for lesions situated close to large vessels or hollow viscera, as the first can decrease heat generation and the latter can be damaged by the procedure itself; it is more cumbersome, needs anaesthesiology assistance in most of the cases and, accordingly to early reports, is aggravated by a higher complication rate and higher costs. A major advantage of RF is the achievement of complete ablation of the neoplastic lesion with less sessions than PEI. This advantage impacts on the "quality of life" of the patient, who prefers to be cured in a single session rather than by the multisession approach of PEI.

When the present study began in January 2001, no randomised controlled trial comparing RF and PEI had been published and no data were available on mid-long term local tumor progression and on comparative survival rate after either treatment. Some retrospective studies about the primary effectiveness had been published.

The aim of our study was to compare the effectiveness of RF versus PEI in a randomised controlled trial: our primary end point was to evaluate the local control (sustained complete response) after 1 year from the treatment of every lesion defined as HCC in the single patient at the beginning of the trial; secondary end points included the primary effectiveness (early complete response)of the treatment after 1-2 months,the overall survival at four years, the complication rate, and the costs.

Study Type

Interventional

Enrollment

240

Phase

  • Phase 3

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

  • Italy
      • Torino, Italy, 10126
        • Azienda Ospedaliera San Giovanni Battista Di Torino

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

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Included were cirrhotic patients in Child-Pugh class A/B with 1 to 3 HCC nodes of ≤ 30mm in diameter.

Exclusion Criteria:

  • Excluded were patients without liver cirrhosis, in Child-Pugh class C, with a platelets count <40000, INR >1.75, PTT >40sec, hypo vascular HCC, lesions not detectable by ultrasonography (US), lesions close (≤1cm) to the gallbladder, hepatic hilum, colon or stomach, with venous invasion or metastatic disease

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 Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Sustained complete response at one year after the treatment.

Secondary Outcome Measures

Outcome Measure
complications
early complete response(forty days after treatment)
overall survival at the fourth year after the first treatment
costs.

Collaborators and Investigators

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

Sponsor

Azienda Ospedaliera San Giovanni Battista

Investigators

  • Principal Investigator: Franco Brunello, MD, Azienda Ospedaliera San Giovanni Battista Di Torino

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

January 1, 2001

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

July 19, 2006

First Submitted That Met QC Criteria

July 19, 2006

First Posted (Estimate)

July 21, 2006

Study Record Updates

Last Update Posted (Estimate)

July 25, 2006

Last Update Submitted That Met QC Criteria

July 21, 2006

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3909/562/35/2000

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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