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Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy
Conditions
Liver Tumor
Conditions: official terms
Liver Neoplasms
Conditions: Keywords
liver tumor, Two stage hepatectomy, Hypertrophy, laparoscopy, ALPPS
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: Laparoscopic ALPPS
Type: Procedure
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
- 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
Location
Southwest Hospital
Chongqing, China
Status: Recruiting
Contact: Shuguo Zheng, Professor - 86-13508308676 - shuguozh@gmail.com
Start Date
July 2014
Completion Date
August 2017
Sponsors
Shuguo Zheng, MD
Source
Southwest Hospital, China
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page