Study Stopped
The post-treatment recurrence rate was expected to be different between two treatment groups.
A Study Comparing Radiofrequency Ablation and Hepatic Resection for Hepatocellular Carcinoma
A Prospective Randomized Study to Compare the Efficacy of Radiofrequency Ablation and Hepatic Resection as a Primary Treatment for Single Small Hepatocellular Carcinoma
1 other identifier
interventional
68
0 countries
N/A
Brief Summary
The purpose of this prospective randomized study is to compare the efficacy and safety of radiofrequency ablation and hepatic resection for small hepatocellular carcinomas with very homogeneous underlying conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2005
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 20, 2015
CompletedFirst Posted
Study publicly available on registry
June 26, 2015
CompletedJune 26, 2015
June 1, 2015
7.8 years
June 20, 2015
June 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
The patient survival
From the intervention up to 5 years or until the death of the participant whichever came first
Secondary Outcomes (1)
The disease-free survival
From the intervention up to 5 years or until hepatocellular carcinoma recurrence whichever came first
Study Arms (2)
Hepatic resection
EXPERIMENTALHepatic resection is performed as a primary treatment for hepatocellular carcinoma.
Radiofrequency ablation
EXPERIMENTALRadiofrequency ablation is performed as a primary treatment for hepatocellular carcinoma.
Interventions
Anatomical surgical resection of the liver including the tumor
Percutaneous ablation using radiofrequency under the imaging guidance
Eligibility Criteria
You may qualify if:
- Age between 20 and 70 years
- Child-Pugh class A (score 5-6)
- Single hepatocellular carcinoma
- Maximal diameter of the tumor from 2 to 4 cm when measured on MRI or CT (The diameter on MRI was measured prior to that on CT)
- No previous treatment
- Platelet count \> 80,000/mm3
You may not qualify if:
- HCC abutting main hepatic veins or the first branches of the main portal vein
- HCC abutting vessels ≥ 0.5 cm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- National Cancer Center, Koreacollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kyung-Suk Suh, ME, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 20, 2015
First Posted
June 26, 2015
Study Start
July 1, 2005
Primary Completion
May 1, 2013
Study Completion
July 1, 2013
Last Updated
June 26, 2015
Record last verified: 2015-06