RALPPS Venus ALPPS for Hepatocellular Carcinoma

Southwest Hospital, China32 enrolled

Overview

Currently，the "ALPPS" (associating liver partition with portal vein ligation for staged hepatectomy) procedure which enables the rapid growth of the future liver remnant and extends surgical indication to patients with mid-advanced stage hepatocellular carcinoma becomes a research hot spot. However, the procedure has a high morbidity and mortality rate.Using radio-frequency ablation instead of in-situ split of liver to avoid forming a coagulation band in stage I will reduce the incidence of complications（bile leakage, abdominal infection,hemorrhage e.t.) The investigators named this technique as Radio-frequency Assisted Liver Partition with Portal vein ligation for staged hepatectomy （RALPPS）.Investigators hypothesized that the RALPPS might result in lower morbidity and mortality rate than ALPPS in the treatment of hepatocellular carcinoma . This Prospective Randomized Controlled Trial is on the Safety and Efficacy of radio-frequency assisted liver partition with portal vein ligation for staged hepatectomy for hepatocellular carcinoma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * An insufficient future liver remnant(FLR\<30% in normal hepatic function or FLR\<40% with hepatic cirrhosis or after chemotherapy） * Liver function of Child-Pugh Class A or B. * Liver Reserve Function：ICG-R15≤10％ * No evidence of coagulopathy: platelet count \> 50 × 109/L and a prolonged prothrombin time of \< 5 seconds. Exclusion Criteria: * Patients met the inclusion criteria but declined to participate. * Patients with severe portal hypertension, a history of esophageal variceal hemorrhage, severe hypersplenism syndrome, or refractory ascites. * Main portal vein、inferior vena cava、common hepatic duct and hepatic vein have tumor thrombus. * Extrahepatic or lymph node metastasis

Outcomes

Primary Outcomes

morbidity during perioperation

complications include bile leakage, abdominal infection, hemorrhage, PHLF e.t.

Time frame: 2 years

mortality during perioperation