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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00844454
First received: February 13, 2009
Last updated: August 10, 2009
Last verified: August 2009
  Purpose

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).


Condition Intervention Phase
Hepatocellular Carcinoma
Procedure: multi-pronged ethanol ablation
Procedure: radiofrequency ablation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Ethanol Ablation Using a Multi-pronged Needle and Radiofrequency Ablation of Early-stage Hepatocellular Carcinoma: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Local treatment responses [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease-free survivals and overall survivals [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: May 2008
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QFEA
multi-pronged ethanol ablation
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.
Active Comparator: RFA
radiofrequency ablation
Procedure: radiofrequency ablation
Under ultrasound guidance, insert an applicator into the tumor percutaneously and then deliver radiofrequency energy to destroy the whole tumor tissue.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844454

Contacts
Contact: Mingde Lu, Professor +862087765183 lumd@21cn.com

Locations
China, Guangdong
The First Affiliated Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Mingde Lu, Professor    +862087765183    lumd@21cn.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Mingde Lu, Prof. Sun Yat-sen University
  More Information

No publications provided

Responsible Party: The First Affiliated Hospital of Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00844454     History of Changes
Other Study ID Numbers: EARFArct, EARFArct2007
Study First Received: February 13, 2009
Last Updated: August 10, 2009
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
hepatocellular carcinoma
PEI
RF ablation
tumor ablation

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014