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

Phase 3
Not Enrolling
Carcinoma, Hepatocellular

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Trial Information

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

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Sustained complete response at one year after the treatment.

Principal Investigator

Franco Brunello, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Azienda Ospedaliera San Giovanni Battista di Torino


Italy: Ministry of Health

Study ID:




Start Date:

January 2001

Completion Date:

March 2006

Related Keywords:

  • Carcinoma, Hepatocellular
  • percutaneous ethanol injection
  • radiofrequency
  • liver cirrhosis
  • carcinoma, hepatocellular
  • Carcinoma
  • Liver Cirrhosis
  • Carcinoma, Hepatocellular