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

This study has been terminated.
Sponsor:
Information provided by:
Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier:
NCT00355212
First received: July 19, 2006
Last updated: July 21, 2006
Last verified: March 2006
  Purpose

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.


Condition Intervention Phase
Carcinoma, Hepatocellular
Procedure: percutaneous ablation of hepatocellular carcinoma
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Study Between Radiofrequency and Ethanol Injection for the Ablation of Small Hepatocellular Carcinoma Associated With Liver Cirrhosis

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera San Giovanni Battista:

Primary Outcome Measures:
  • Sustained complete response at one year after the treatment.

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

Estimated Enrollment: 240
Study Start Date: January 2001
Estimated Study Completion Date: March 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00355212

Locations
Italy
Azienda Ospedaliera San Giovanni Battista di Torino
Torino, Italy, 10126
Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista
Investigators
Principal Investigator: Franco Brunello, MD Azienda Ospedaliera San Giovanni Battista di Torino
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00355212     History of Changes
Other Study ID Numbers: 3909/562/35/2000
Study First Received: July 19, 2006
Last Updated: July 21, 2006
Health Authority: Italy: Ministry of Health

Keywords provided by Azienda Ospedaliera San Giovanni Battista:
percutaneous ethanol injection
radiofrequency
liver cirrhosis
carcinoma, hepatocellular

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Liver Cirrhosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014