Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy

• Conditions: Liver Tumor

• Registration Number: NCT02203409
• Lead Sponsor: Shuguo Zheng, MD

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-23
• Study First Submitted QC: 2014-07-27
• Study First Posted: 2014-07-29
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-14
• Primary Completion: 2022-08
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
survival rate	3 years	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.

Trial Locations

Locations (1)

Southwest Hospital; 🇨🇳 Chongqing, China