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
|Condition or disease||Intervention/treatment|
|Liver Tumor||Procedure: Laparoscopic ALPPS|
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.
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|
|Estimated Enrollment :||30 participants|
|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|
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
- Safety of the procedure defined as the incidence of postoperative complications and mortality [ Time Frame: within the first 90 days after the first stage ]
- 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.
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
|Contact: Shuguo Zhengfirstname.lastname@example.org|
|Chongqing, China, 400038|
|Contact: Shuguo Zheng, Professor 86-13508308676 email@example.com|
|Study Director:||Shuguo Zheng||Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University|