A Study Comparing Radiofrequency Ablation and Hepatic Resection for Hepatocellular Carcinoma

Overview

The purpose of this prospective randomized study is to compare the efficacy and safety of radiofrequency ablation and hepatic resection for small hepatocellular carcinomas with very homogeneous underlying conditions.

Full Title of Study: “A Prospective Randomized Study to Compare the Efficacy of Radiofrequency Ablation and Hepatic Resection as a Primary Treatment for Single Small Hepatocellular Carcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2013

Interventions

  • Procedure: Hepatic resection
    • Anatomical surgical resection of the liver including the tumor
  • Procedure: Radiofrequency ablation
    • Percutaneous ablation using radiofrequency under the imaging guidance

Arms, Groups and Cohorts

  • Experimental: Hepatic resection
    • Hepatic resection is performed as a primary treatment for hepatocellular carcinoma.
  • Experimental: Radiofrequency ablation
    • Radiofrequency ablation is performed as a primary treatment for hepatocellular carcinoma.

Clinical Trial Outcome Measures

Primary Measures

  • The patient survival
    • Time Frame: From the intervention up to 5 years or until the death of the participant whichever came first

Secondary Measures

  • The disease-free survival
    • Time Frame: From the intervention up to 5 years or until hepatocellular carcinoma recurrence whichever came first

Participating in This Clinical Trial

Inclusion Criteria

1. Age between 20 and 70 years 2. Child-Pugh class A (score 5-6) 3. Single hepatocellular carcinoma 4. Maximal diameter of the tumor from 2 to 4 cm when measured on MRI or CT (The diameter on MRI was measured prior to that on CT) 5. No previous treatment 6. Platelet count > 80,000/mm3 Exclusion Criteria:

1. HCC abutting main hepatic veins or the first branches of the main portal vein 2. HCC abutting vessels ≥ 0.5 cm

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Collaborator
    • National Cancer Center, Korea
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kyung-Suk Suh, Professor – Seoul National University Hospital
  • Overall Official(s)
    • Kyung-Suk Suh, ME, PhD, Study Director, Seoul National University Hospital

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