Multi-pronged Ethanol Ablation and Radiofrequency Ablation of Early-stage Hepatocellular Carcinoma
QPEAvsRFA
Ethanol Ablation Using a Multi-pronged Needle and Radiofrequency Ablation of Early-stage Hepatocellular Carcinoma: a Randomized Clinical Trial
2 other identifiers
interventional
81
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hepatocellular-carcinoma
Started May 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 13, 2009
CompletedFirst Posted
Study publicly available on registry
February 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedOctober 8, 2019
October 1, 2019
2 years
February 13, 2009
October 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Local treatment responses
2 years
Secondary Outcomes (1)
Disease-free survivals and overall survivals
3 years
Study Arms (2)
QFEA
EXPERIMENTALmulti-pronged ethanol ablation
RFA
ACTIVE COMPARATORradiofrequency ablation
Interventions
Under ultrasound guidance, insert an applicator into the tumor percutaneously and then inject ethanol to destroy the whole tumor tissue.
Under ultrasound guidance, insert an applicator into the tumor percutaneously and then deliver radiofrequency energy to destroy the whole tumor tissue.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Vascular invasion and extrahepatic spread
- Patients allergic to ethanol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510080, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mingde Lu, Prof.
Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Medical Ultrasound
Study Record Dates
First Submitted
February 13, 2009
First Posted
February 16, 2009
Study Start
May 1, 2008
Primary Completion
May 1, 2010
Study Completion
May 1, 2011
Last Updated
October 8, 2019
Record last verified: 2019-10