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
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, see Learn About Clinical Studies.

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, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
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 September 22, 2014