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

Sun Yat-sen University

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: radiofrequency ablation; Procedure: multi-pronged ethanol ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT00844454

EARFArct2007

EARFArct

Details and patient eligibility

About

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).

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 2 patient groups

QFEA

Experimental group

Description:

multi-pronged ethanol ablation

Treatment:

Procedure: multi-pronged ethanol ablation

RFA

Active Comparator group

Description:

radiofrequency ablation

Treatment:

Procedure: radiofrequency ablation