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Radiofrequency Ablation vs. Hepatic Resection for the Treatment of Hepatocellular Carcinomas Smaller Than 2 cm.A Prospective and Randomized Clinical Trial

Phase 4
18 Years
75 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

Radiofrequency Ablation vs. Hepatic Resection for the Treatment of Hepatocellular Carcinomas Smaller Than 2 cm.A Prospective and Randomized Clinical Trial

With the development of medical science, more and more patients are being diagnosed with
hepatocellular carcinoma (HCC) at an early stage (single ≤ 5 cm in diameter or ≤ 3 nodules,
≤ 3 cm in diameter) allowing for radical treatment by hepatic resection (HR), liver
transplantation, or percutaneous ablation . Liver transplantation can eliminate the tumor
and cirrhosis at the same time, and is considered to be the most appropriate treatment for
these patients. However, the lack of liver donors is a major limitation. Until now, HR has
still been considered as the first-choice treatment for these patients, which may offer a
5-year survival rate above 50%. Percutaneous ablation, including percutaneous ethanol
injection (PEI) and percutaneous radiofrequency ablation (PRFA), is usually considered to be
a second-choice treatment for small HCC which is unresectable due to impaired liver
function, and liver transplantation is not indicated.

Recently, a clinical trial has shown that PRFA is as effective as HR for small HCC in terms
of overall survival and disease-free survival. This has prompted some authors to suggest
that PRFA could be more suitable than HR for early stage HCC. Some authors also have
suggested that PRFA can be considered the treatment of choice for patients with single HCC ≤
2.0 cm, even when HR is possible. On the other hand, some tumors (subcapsular location,
adjacent to intestinal loops or main bile ducts) may be unsuitable for PRFA because of the
risk of bleeding, tumor seeding, bile leakage, perforation, and so on. Furthermore, in our
previous experience, some tumors (with deep locations, which were included as "central HCC")
may be also unsuitable for HR because of risks of more injury of normal liver tissue, blood
loss after resection, and so on. Therefore, the appropriate therapeutic option for these HCC
tumors ≤ 2 cm, especially for central HCC, is still under debate. To clarify this issue, the
investigators conducted a study that included a consecutive series of patients with single
resectable HCC < 2.0 cm in diameter, who underwent PRFA or HR.

Inclusion Criteria:

1. age 18 - 75 years, who refused liver transplantation;

2. presence of solitary HCC measuring ≤ 2.0 cm in diameter;

3. resectable disease, which is defined as the possibility of completely removing all
tumors and retaining a sufficient liver remnant to maintain liver function, as
assessed by our surgery team;

4. Eastern Co-operative Oncology Group performance (ECOG) status 0 (15);

Exclusion Criteria:

1. severe coagulation disorders (prothrombin activity < 40% or a platelet count of <
40,000 / mm3;

2. the presence of vascular invasion or extrahepatic spread on imaging;

3. Child-Pugh class C liver cirrhosis or evidence of hepatic decompensation including
ascites, esophageal or gastric variceal bleeding, or hepatic encephalopathy;

4. previous treatment.

Type of Study:


Study Design:

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

Outcome Measure:

overall survival

Outcome Time Frame:

3 year

Safety Issue:


Principal Investigator

min-shan chen, Ph.D.,M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Center, Sun Yat-set University


China: Ministry of Health

Study ID:




Start Date:

March 2010

Completion Date:

May 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular Carcinoma
  • RFA
  • HR
  • Carcinoma
  • Carcinoma, Hepatocellular