Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy

Study Overview
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Brief Summary
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The purpose of this research is evaluate the results with laparoscopic ALPPS procedure in a single center. The validity, feasibility and limitations were assessed objectively through our clinical prospective study.The investigators expect laparoscopic ALPPS is safe, effective and feasible.

Detailed Description
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Background: Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a breakthrough in the field of hepatobiliary surgery in recent years，which stimulates the remnant liver volume(RLV) grew by 74%-87.2% in 9 to 13 days。The published literature reported that the two stages of ALPPS are the conventional laparotomy surgery，Patients need to undergo the injury of two open operations in a short time. The incidence of postoperative complications and mortality rate is as high as 53% -73% and 12%-27%.The aim of this study was to evaluate the results with laparoscopic ALPPS procedure in a single center, with special emphasis in validity, feasibility and limitations. Results: Clinical data include: operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function, long-term curative effect and survival time were collected and analysed. Statistical method:groups t-test ，univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis ，Kaplan-Meier survival analysis，Log-rank survival curves were used.

Official Title
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Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy

Conditions
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Liver Tumor

Intervention / Treatment
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* Procedure: Laparoscopic ALPPS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with marginally resectable or primarily non-resectable locally advanced liver tumors Insufficient future liver remnant (FLR) either in volume or quality Exclusion Criteria: Unresectable liver metastases in the future liver remnant or unresectable extrahepatic metastases Severe portal hypertension High anesthesiological risk Unresectable primary tumor

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laparoscopic ALPPS group<br>Patients with small future liver remnant who are operated with the Associating Liver Partition and Portal vein ligation for Staged hepatectomy approach | Procedure: Laparoscopic ALPPS<br>* Laparoscopic Associating Liver Partition and Portal Vein Ligation for Two-stage Hepatectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the procedure defined as the incidence of postoperative complications and mortality |  | within the first 90 days after the first stage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate | follow-up after the surgery every 3months, to understand relapse, death, statistics 1-year, 3-year overall survival rates，disease-free survival rates , recurrence and metastasis rate. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver tumor, Two stage hepatectomy, Hypertrophy, laparoscopy, ALPPS