Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety of the procedure defined as the incidence of postoperative complications and mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with marginally resectable or primarily non-resectable locally advanced liver tumors
- •Insufficient future liver remnant (FLR) either in volume or quality
排除标准
- •Unresectable liver metastases in the future liver remnant or unresectable extrahepatic metastases
- •Severe portal hypertension
- •High anesthesiological risk
- •Unresectable primary tumor
结局指标
主要结局
Safety of the procedure defined as the incidence of postoperative complications and mortality
时间窗: within the first 90 days after the first stage
次要结局
- survival rate(3 years)
研究者
Shuguo Zheng, MD
Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department
Southwest Hospital, China