Radiofrequency Ablation Assisted Hepatectomy Versus Hepatectomy Alone for Advanced Hepatocellular Carcinoma

Army Medical University

Status: Unknown

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Hepatectomy; Procedure: RFA assisted Hepatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01713244

SKLKF201209

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Hepatectomy

Active Comparator group

Description:

Using Hepatectomy for the treatment of advanced HCC

Treatment:

Procedure: Hepatectomy

RFA assisted Hepatectomy

Experimental group

Description:

Ablating the liver tissue around the tumor before hepatectomy.

Treatment:

Procedure: RFA assisted Hepatectomy