A Study Comparing Radiofrequency Ablation and Hepatic Resection for Hepatocellular Carcinoma

June 25, 2015 updated by: Kyung-Suk Suh, Seoul National University Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hepatic resection
Hepatic resection is performed as a primary treatment for hepatocellular carcinoma.
Procedure: Hepatic resection
Anatomical surgical resection of the liver including the tumor
Experimental: Radiofrequency ablation
Radiofrequency ablation is performed as a primary treatment for hepatocellular carcinoma.
Procedure: Radiofrequency ablation
Percutaneous ablation using radiofrequency under the imaging guidance

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

National Cancer Center, Korea

Investigators

  • Study Director: Kyung-Suk Suh, ME, PhD, Seoul National University Hospital

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

July 1, 2005

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 20, 2015

First Submitted That Met QC Criteria

June 25, 2015

First Posted (Estimate)

June 26, 2015

Study Record Updates

Last Update Posted (Estimate)

June 26, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0520090

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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