A Study Comparing Radiofrequency Ablation and Hepatic Resection for Hepatocellular Carcinoma

NCT ID: NCT02482909

Last Updated: 2015-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2013-07-31

Brief Summary

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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

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Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hepatic resection

Hepatic resection is performed as a primary treatment for hepatocellular carcinoma.

Group Type EXPERIMENTAL

Hepatic resection

Intervention Type PROCEDURE

Anatomical surgical resection of the liver including the tumor

Radiofrequency ablation

Radiofrequency ablation is performed as a primary treatment for hepatocellular carcinoma.

Group Type EXPERIMENTAL

Radiofrequency ablation

Intervention Type PROCEDURE

Percutaneous ablation using radiofrequency under the imaging guidance

Interventions

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Hepatic resection

Anatomical surgical resection of the liver including the tumor

Intervention Type PROCEDURE

Radiofrequency ablation

Percutaneous ablation using radiofrequency under the imaging guidance

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kyung-Suk Suh

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyung-Suk Suh, ME, PhD

Role: STUDY_DIRECTOR

Seoul National University Hospital

Other Identifiers

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0520090

Identifier Type: -

Identifier Source: org_study_id

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