Hepatocellular Carcinoma
Conditions
Keywords
hepatocellular carcinoma, PEI, RF ablation, tumor ablation
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.
Interventions
PROCEDUREmulti-pronged ethanol ablation
Under ultrasound guidance, insert an applicator into the tumor percutaneously and then inject ethanol to destroy the whole tumor tissue.
PROCEDUREradiofrequency ablation
Under ultrasound guidance, insert an applicator into the tumor percutaneously and then deliver radiofrequency energy to destroy the whole tumor tissue.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local treatment responses | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survivals and overall survivals | 3 years |
Countries
China
Outcome results
None listed