Radiofrequency-assisted Hepatectomy on the Outcomes of HCC Patients With Cirrhosis

Army Medical University

Status: Unknown

Conditions: Cirrhosis; Hepatocellular Carcinoma

Treatments: Procedure: Conventional Hepatectomy; Procedure: Radiofrequency-assisted Hepatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01992978

SWHB2013-005

Details and patient eligibility

About

Surgical resection is the most effective treatment of primary and secondary liver tumors. Technical innovations have mainly focused on minimizing bleeding during transection of the hepatic parenchyma because excessive hemorrhage and the need for blood transfusion are associated with increased postoperative morbidity and mortality. Recently,radiofrequency-assisted（RFA）hepatectomy has developed rapidly and gained widespread acceptance for the treatment of hepatocellular carcinomas（HCC），but its influence on the prognosis of HCC patients，especially for those with cirrhosis，is still controversial. Therefore, we design this prospective clinical trial to explore the effect of RFA hepatectomy versus the conventional hepatectomy on the outcomes of perioperative period and prognosis of HCC patients with cirrhosis.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged from 18 to 65 years , no gender restriction.
• Clinical diagnosis of resectable HCC.
• Preoperative liver function test showed Child-Pugh Class A or B.
• Indocyanine green retention at 15 minutes (ICG-15) of <30%.
• Acceptable clotting profile :platelet count > 50 x 109/L and a prolonged prothrombin time of < 5 seconds.
• Enough relative residual liver volume (%RLV) ≥ 40%.
• No tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava.
• No other anti-tumor therapy received before the treatment.
• No metastasis in lymphnode or other organs.
• Written consent inform assigned.

Exclusion criteria

• Pregnancy.
• Intraoperative findings of tumor rupture，extrahepatic tumor or lymphnode metastasis.
• Tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

radiofrequency-assisted resection group（RF-R)

Experimental group

Description:

Radiofrequency-assisted resection: separating the tumor from liver by using the probe of radiofrequency to block the arterial and vessels before parenchymal transection.

Treatment:

Procedure: Radiofrequency-assisted Hepatectomy

conventional liver resection group（CLR-R）

Active Comparator group

Description:

Conventional liver resection group: hepatectomy only without RF assisted during parenchymal transection.Separating and dissecting the tumor with the routine clamp-crushing technical.

Treatment:

Procedure: Conventional Hepatectomy