Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma, Radiofrequency Ablation, Hepatectomy, Recurrence
Brief summary
RFA has become a standard method in the treatment of small HCC(≤2 cm) due to its ease of use, safety, cost-effectiveness, and minimal invasiveness. It can ablated and blocked the small vessels while destroyed the tumor cell in situ. Surgical resection is the most widely accepted treatment for the patients with advanced hepatocellular carcinoma in the Asian countries. But the effectiveness of hepatectomy was depressed because of the high recurrence rate. The spreading of the cancer cell along the portal vein or the hepatic vein system during the operation account for the tumor recurrence. Using RFA to ablate and block the small vessels around the tumor before resection will reduce the spreading of the cancer cell. Investigators hypothesized that the RFA assisted hepatectomy might result in lower recurrence rate than hepatectomy alone in the treatment of advanced HCC. Thus, the purpose of this study was to prospectively compare the effects of RFA assisted hepatectomy with hepatectomy alone for the treatment of advanced HCC.
Interventions
PROCEDURERFA assisted Hepatectomy
Using RFA to ablate and block the small vessels around the tumor before resection to reduce the spreading of the cancer cell.
PROCEDUREHepatectomy
Treat the advanced HCC with the hepatectomy only.
Sponsors
Southwest Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of HCC confirmed at our hospital. 2. Intrahepatic tumor count no higher than 3 and a minimum tumor diameter \> 3 cm, but no more than 8cm. 3. Liver function of Child-Pugh Class A or B. 4. Tumors lacked intrahepatic and extrahepatic metastasis. 5. Tumors had not invaded the portal vein, the hepatic vein trunk or the secondary branches. 6. Indocyanine green retention at 15 minutes (ICG-15) of \<10%. 7. No evidence of coagulopathy: platelet count \> 50 × 109/L and a prolonged prothrombin time of \< 5 seconds. 8. No other anti-tumor therapy received before the treatment. -
Exclusion criteria
1. Patients met the inclusion criteria but declined to participate. 2. Patients with severe portal hypertension, a history of esophageal variceal hemorrhage, severe hypersplenism syndrome, or refractory ascites. 3. Patients whose permanent pathology after treatment suggested metastatic liver cancer or primary liver cancer of another tissue type.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free Survival | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | 2 years |
Other
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | 2 years |
Countries
China
Contacts
Primary ContactKai Feng, M.D
Outcome results
None listed