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

Hepatocellular Carcinoma Clinical Trial

— QPEAvsRFA  

Official title:

Ethanol Ablation Using a Multi-pronged Needle and Radiofrequency Ablation of Early-stage Hepatocellular Carcinoma: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00844454
• Other study ID #: EARFArct
• Secondary ID: EARFArct2007
• Status: Completed
• Phase: N/A
• Start date: May 2008
• Est. completion date: May 2011

Study information

• Verified date: October 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• multi-pronged ethanol ablation
Under ultrasound guidance, insert an applicator into the tumor percutaneously and then inject ethanol to destroy the whole tumor tissue.
• radiofrequency ablation
Under ultrasound guidance, insert an applicator into the tumor percutaneously and then deliver radiofrequency energy to destroy the whole tumor tissue.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local treatment responses		2 years
Secondary	Disease-free survivals and overall survivals		3 years