Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy

January 13, 2022 updated by: Shuguo Zheng, MD
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Chongqing, China, 400038
        • Recruiting
        • Southwest Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

30

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Laparoscopic ALPPS group
Patients with small future liver remnant who are operated with the "Associating Liver Partition and Portal vein ligation for Staged hepatectomy" approach
Procedure: Laparoscopic ALPPS
Laparoscopic Associating Liver Partition and Portal Vein Ligation for Two-stage Hepatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of the procedure defined as the incidence of postoperative complications and mortality
Time Frame: within the first 90 days after the first stage
within the first 90 days after the first stage

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival rate
Time Frame: 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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shuguo Zheng, MD

Investigators

  • Study Director: Shuguo Zheng, Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

July 23, 2014

First Submitted That Met QC Criteria

July 27, 2014

First Posted (Estimate)

July 29, 2014

Study Record Updates

Last Update Posted (Actual)

January 14, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWHZSG005
  • 30972948 (Other Grant/Funding Number: National Natural Science Foundation of China)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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