Radiofrequency Ablation Assisted Hepatectomy Versus Hepatectomy Alone for Advanced Hepatocellular Carcinoma

Not Applicable

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Hepatectomy; Procedure: RFA assisted Hepatectomy

• Registration Number: NCT01713244
• Lead Sponsor: Southwest Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-21
• Study First Submitted QC: 2012-10-23
• Study First Posted: 2012-10-24
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-19
• Last Update Posted: 2015-11-20
• Primary Completion: 2016-10
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hepatectomy	Hepatectomy	Using Hepatectomy for the treatment of advanced HCC
RFA assisted Hepatectomy	RFA assisted Hepatectomy	Ablating the liver tissue around the tumor before hepatectomy.

Primary Outcome Measures

Name	Time	Method
Recurrence-free Survival	2 years

Secondary Outcome Measures

Name	Time	Method
Overall Survival	2 years

Trial Locations

Locations (1)

Institute of hepatobiliary surgery,Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China