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Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy

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ClinicalTrials.gov Identifier: NCT02203409
Recruitment Status : Unknown
Verified July 2014 by Shuguo Zheng, MD, Southwest Hospital, China.
Recruitment status was:  Recruiting
First Posted : July 29, 2014
Last Update Posted : July 9, 2015
Sponsor:
Information provided by (Responsible Party):
Shuguo Zheng, MD, Southwest Hospital, China

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.

Condition or disease Intervention/treatment
Liver Tumor Procedure: Laparoscopic ALPPS

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy
Study Start Date : July 2014
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

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




Primary Outcome Measures :
  1. Safety of the procedure defined as the incidence of postoperative complications and mortality [ Time Frame: within the first 90 days after the first stage ]

Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
30
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203409


Contacts
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Contact: Shuguo Zheng 86-13508308676 shuguozh@gmail.com

Locations
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China
Southwest Hospital Recruiting
Chongqing, China, 400038
Contact: Shuguo Zheng, Professor    86-13508308676    shuguozh@gmail.com   
Sponsors and Collaborators
Shuguo Zheng, MD
Investigators
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Study Director: Shuguo Zheng Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
Publications:

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Responsible Party: Shuguo Zheng, MD, Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT02203409    
Other Study ID Numbers: SWHZSG005
30972948 ( Other Grant/Funding Number: National Natural Science Foundation of China )
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: July 9, 2015
Last Verified: July 2014
Keywords provided by Shuguo Zheng, MD, Southwest Hospital, China:
liver tumor
Two stage hepatectomy
Hypertrophy
laparoscopy
ALPPS
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases