A Prospective Study: Magnetic Spiderman for Preparation of Donor Livers' Inferior Vena Cava
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The number of damaged points on HVC
研究概览
简要总结
Due to many vascular branches on the supra-hepatic vena cava (SHVC) and infra-hepatic vena cava (IHVC), in the whole procedures of preparation of liver donation, preparation of hepatic vena cava (HVC) is the most key and troublesome step. Magnetic Spiderman (MS) is a novel surgical instrument, designed and created to solve the vital problems of preparation of liver donation's HVC. Therefore, the aim of this study is to evaluate the feasibility and security of MS when using it prepare the liver donation's HVC.
详细描述
From January 1 2020 to June 30 2020, after inclusion and exclusion, donors' livers will be divided to MS group and manual (MA) group. In MS group, MS grips the SHVC and IHVC, respectively. MS's magnets are adsorbed on the wall of the basin and MS can pull the HVC accordingly. By changing the position of MS on the wall of the basin, the attending can expose the surgical field that make the operation convenient. In MA group, assistants use vessel forceps to pull the HVC according to the attending's requirements. In both groups, right adrenal vein, phrenic veins and other branches of the HVC are isolated and ligated, then SHVC and IHVC where MS's clamps gripped are cut off. After preparation, the SHVC and IHVC remain at least 1.5 cm. Excess diaphragms are removed. Outcomes of two groups are compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients receiving donation after cardiac death in the First Affiliated Hospital, School of Medicine, Xi'an Jiaotong University.
排除标准
- •patients whose age<18, or >60
- •patients who do not have intact clinical data
- •patients who are inability to participate in follow-up
- •patients who undergo split liver transplantation
结局指标
主要结局
The number of damaged points on HVC
时间窗: measured at the time of the end of preparation HVC; up to 1 hour
the number of damaged points on the HVC during the preparation
Operation time
时间窗: measured at the time of the end of preparation HVC; up to 1 hour
operation time of preparation of HVC
The number of assistants
时间窗: measured at the time of the end of preparation HVC; up to 1 hour
the number of assistants ensuring smooth operation according to attending's requirement
HVC hemorrhage
时间窗: measured at the time of liver implanted to the recipient; up to 1 hour
Whether HVC hemorrhage after implantation
Leak test
时间窗: measured at the time of the end of preparation HVC; up to 1 hour
we use nondestructive vascular forceps to occlude the SHVC and IHVC, and perfused about 100 ml organ preservation solution through portal vein. If HVC and portal vein bulge and does not leak, the leak test is negative. Otherwise, it is positive.
次要结局
- Frequency of MS's detachment(measured at the time of the end of preparation HVC; up to 1 hour)