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Trial Title:
Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy
NCT ID:
NCT02203409
Condition:
Liver Tumor
Conditions: Official terms:
Liver Neoplasms
Conditions: Keywords:
liver tumor
Two stage hepatectomy
Hypertrophy
laparoscopy
ALPPS
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Laparoscopic ALPPS
Description:
Laparoscopic Associating Liver Partition and Portal Vein Ligation for Two-stage
Hepatectomy
Arm group label:
Laparoscopic ALPPS group
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.
Criteria for eligibility:
Study pop:
30
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Southwest Hospital
Address:
City:
Chongqing
Zip:
400038
Country:
China
Status:
Recruiting
Contact:
Last name:
Shuguo Zheng, Professor
Phone:
86-13508308676
Email:
shuguozh@gmail.com
Start date:
July 2014
Completion date:
August 2022
Lead sponsor:
Agency:
Shuguo Zheng, MD
Agency class:
Other
Source:
Southwest Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02203409
