Clinical trial NCT01713244: Radiofrequency Ablation Assisted Hepatectomy Versus Hepatectomy Alone for Advanced Hepatocellular Carcinoma
Official title: A Randomized Controlled Trial of Radiofrequency Ablation Assisted Hepatectomy and Hepatectomy Alone in the Treatment of Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Radiofrequency Ablation
Hepatectomy
Recurrence
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2012-10-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence-free Survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years
Other outcomes:
measure: Number of participants with adverse events
timeFrame: 2 years
Locations:
city: Chongqing
country: China
facility: Institute of hepatobiliary surgery,Southwest Hospital
state: Chongqing
Study officials:
affiliation: Institute of hepatobiliary surgery,Southwest Hospital
name: Kuansheng Ma, Ph.D
role: STUDY_DIRECTOR
References: