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Completed

NCT Number: NCT00844454

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

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).

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multi-pronged ethanol ablation

Procedure

Under ultrasound guidance, insert an applicator into the tumor percutaneously and then inject ethanol to destroy the whole tumor tissue.

Radiofrequency ablation

Procedure

Under ultrasound guidance, insert an applicator into the tumor percutaneously and then deliver radiofrequency energy to destroy the whole tumor tissue.

Primary outcomes

  1. Local treatment responses

    Time frame: 2 years

Secondary outcomes

  1. Disease-free survivals and overall survivals

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Acronym: QPEAvsRFA

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Feb 16, 2009
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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