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Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy

Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02203409
Enrollment
30
Registered
2014-07-29
Start date
2014-07-31
Completion date
2022-08-31
Last updated
2022-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Tumor

Keywords

liver tumor, Two stage hepatectomy, Hypertrophy, laparoscopy, ALPPS

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.

Interventions

Laparoscopic Associating Liver Partition and Portal Vein Ligation for Two-stage Hepatectomy

Sponsors

Shuguo Zheng, MD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Safety of the procedure defined as the incidence of postoperative complications and mortalitywithin the first 90 days after the first stage

Secondary

MeasureTime frameDescription
survival rate3 yearsfollow-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.

Countries

China

Contacts

Primary ContactShuguo Zheng
shuguozh@gmail.com86-13508308676

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026