search
Back to results

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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
multi-pronged ethanol ablation
radiofrequency ablation
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, PEI, RF ablation, tumor ablation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Sun Yat-Sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QFEA

RFA

Arm Description

multi-pronged ethanol ablation

radiofrequency ablation

Outcomes

Primary Outcome Measures

Local treatment responses

Secondary Outcome Measures

Disease-free survivals and overall survivals

Full Information

First Posted
February 13, 2009
Last Updated
October 5, 2019
Sponsor
Sun Yat-sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT00844454
Brief Title
Multi-pronged Ethanol Ablation and Radiofrequency Ablation of Early-stage Hepatocellular Carcinoma
Acronym
QPEAvsRFA
Official Title
Ethanol Ablation Using a Multi-pronged Needle and Radiofrequency Ablation of Early-stage Hepatocellular Carcinoma: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma, PEI, RF ablation, tumor ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QFEA
Arm Type
Experimental
Arm Description
multi-pronged ethanol ablation
Arm Title
RFA
Arm Type
Active Comparator
Arm Description
radiofrequency ablation
Intervention Type
Procedure
Intervention Name(s)
multi-pronged ethanol ablation
Intervention Description
Under ultrasound guidance, insert an applicator into the tumor percutaneously and then inject ethanol to destroy the whole tumor tissue.
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation
Intervention Description
Under ultrasound guidance, insert an applicator into the tumor percutaneously and then deliver radiofrequency energy to destroy the whole tumor tissue.
Primary Outcome Measure Information:
Title
Local treatment responses
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Disease-free survivals and overall survivals
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingde Lu, Prof.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs