RALPPS Venus ALPPS for Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Randomized Controlled Trial of Radio-frequency Assisted ALPPS（RALPPS）and Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy（ALPPS）in the Treatment of Hepatocellular Carcinoma.

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: RALPPS
* Procedure: ALPPS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ALPPS<br>Using ALPPS for the the treatment of hepatocellular carcinoma. | Procedure: ALPPS<br>* Treat the hepatocellular carcinoma with ALPPS.<br>|
| Experimental: RALPPS<br>Using radiofrequency ablation instead of in-situ split of liver in ALPPS stage I（RALPPS）.Habib 4X was used in RFA. | Procedure: RALPPS<br>* Using radiofrequency ablation assisted ALPPS（RALPPS）instead of in-situ split of liver to form a coagulation band in stage I.Habib 4X was used in RFA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity during perioperation | complications include bile leakage, abdominal infection, hemorrhage, PHLF e.t. | 2 years | 
| mortality during perioperation |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RFA, ALPPS, hepatectomy, morbidity and mortality