We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00844454
Recruitment Status : Unknown
Verified August 2009 by Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : February 16, 2009
Last Update Posted : August 11, 2009
Sponsor:
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: multi-pronged ethanol ablation Procedure: radiofrequency ablation Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2008
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : May 2011

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Local treatment responses [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Disease-free survivals and overall survivals [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: The First Affiliated Hospital of Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00844454     History of Changes
Other Study ID Numbers: EARFArct
EARFArct2007
First Posted: February 16, 2009    Key Record Dates
Last Update Posted: August 11, 2009
Last Verified: August 2009

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
Central Nervous System Depressants
Physiological Effects of Drugs