A Study Comparing Radiofrequency Ablation and Hepatic Resection for Hepatocellular Carcinoma

Not Applicable

Terminated

• Conditions: Carcinoma, Hepatocellular
• Interventions: Procedure: Hepatic resection; Procedure: Radiofrequency ablation

• Registration Number: NCT02482909
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2013-05
• Study Completion: 2013-07
• Status Verified: 2015-06
• Study First Submitted: 2015-06-20
• Study First Submitted QC: 2015-06-25
• Last Update Submitted: 2015-06-25
• Study First Posted: 2015-06-26
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 68

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hepatic resection	Hepatic resection	Hepatic resection is performed as a primary treatment for hepatocellular carcinoma.
Radiofrequency ablation	Radiofrequency ablation	Radiofrequency ablation is performed as a primary treatment for hepatocellular carcinoma.

Primary Outcome Measures

Name	Time	Method
The patient survival	From the intervention up to 5 years or until the death of the participant whichever came first

Secondary Outcome Measures

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