RALPPS Venus ALPPS for Hepatocellular Carcinoma

Not Applicable

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: RALPPS; Procedure: ALPPS

• Registration Number: NCT02299843
• Lead Sponsor: Southwest Hospital, China

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02
• Primary Completion: 2016-11
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RALPPS	RALPPS	Using radiofrequency ablation instead of in-situ split of liver in ALPPS stage I（RALPPS）.Habib 4X was used in RFA.
ALPPS	ALPPS	Using ALPPS for the the treatment of hepatocellular carcinoma.

Primary Outcome Measures

Name	Time	Method
morbidity during perioperation	2 years	complications include bile leakage, abdominal infection, hemorrhage, PHLF e.t.
mortality during perioperation	2 years

Trial Locations

Locations (1)

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