Clinical trial NCT02203409: Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy
Official title: Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Tumor
Keywords: liver tumor
Two stage hepatectomy
Hypertrophy
laparoscopy
ALPPS
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30

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.

Eligibility 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

Primary outcomes:
measure: Safety of the procedure defined as the incidence of postoperative complications and mortality
timeFrame: within the first 90 days after the first stage
Secondary outcomes:
measure: survival rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
Study officials:
affiliation: Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
name: Shuguo Zheng
role: STUDY_DIRECTOR
References:
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