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Multi-pronged Ethanol Ablation and Radiofrequency Ablation of Early-stage Hepatocellular Carcinoma

Not Applicable
Completed
Conditions
Hepatocellular Carcinoma
Interventions
Procedure: multi-pronged ethanol ablation
Procedure: radiofrequency ablation
Registration Number
NCT00844454
Lead Sponsor
Sun Yat-sen University
Brief Summary

The purpose of this study is to compare the effectiveness of percutaneous ethanol ablation using a multi-pronged needle (QFEA) with that of percutaneous radiofrequency ablation (RFA) in the treatment of early-stage hepatocellular carcinoma (HCC).

Detailed Description

Patients with early-stage (single tumor no more than 5 cm or up to 3 tumors each no more than 3 cm in size) primary hepatocellular carcinoma will be randomized into two percutaneous ablation treatment arms, including radiofrequency ablation and multi-pronged ethanol ablation. The local treatment responses, complications,and long-term disease-free survivals and overall survivals are analyzed.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
81
Inclusion Criteria
  • Primary hepatocellular carcinoma, single tumor ≤5 cm or up to 3 tumors each ≤3 cm
  • Ultrasound detectable tumor
  • Liver function classified as Child-Pugh A or B
  • Platelet count > 50,000/mm3, or prothrombin activity > 50%
  • Not suitable for resection or patient refused surgery
Exclusion Criteria
  • Vascular invasion and extrahepatic spread
  • Patients allergic to ethanol

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
QFEAmulti-pronged ethanol ablationmulti-pronged ethanol ablation
RFAradiofrequency ablationradiofrequency ablation
Primary Outcome Measures
NameTimeMethod
Local treatment responses2 years
Secondary Outcome Measures
NameTimeMethod
Disease-free survivals and overall survivals3 years

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-Sen University

🇨🇳

Guangzhou, Guangdong, China

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