Magnetic Spiderman for Preparation of Liver Donation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Study: Magnetic Spiderman for Preparation of Donor Livers' Inferior Vena Cava

Conditions
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Liver Transplant; Complications, Surgical Injury

Intervention / Treatment
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* Device: MS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients receiving donation after cardiac death in the First Affiliated Hospital, School of Medicine, Xi'an Jiaotong University. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MS group<br>In the MS group, the MS grips the HVC through the magnet adsorbed onto the wall of the basin containing the liver. By changing the position of the MS on the wall of the basin, the surgeon is able to expose the surgical field. | Device: MS<br>* Magnetic Spiderman (MS) is a novel surgical instrumentIt. It consists of a circular neodymium iron boron magnet packed in a stainless-steel case with a spring and a jagged clamp, which gives it a spider-like appearance.<br>|
| No Intervention: MA group<br>In MA group, assistants use vessel forceps to pull the HVC according to the attending's requirements. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of damaged points on HVC | the number of damaged points on the HVC during the preparation | measured at the time of the end of preparation HVC; up to 1 hour | 
| Operation time | operation time of preparation of HVC | measured at the time of the end of preparation HVC; up to 1 hour | 
| The number of assistants | the number of assistants ensuring smooth operation according to attending's requirement | measured at the time of the end of preparation HVC; up to 1 hour | 
| Leak test | 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. | measured at the time of the end of preparation HVC; up to 1 hour | 
| HVC hemorrhage | Whether HVC hemorrhage after implantation | measured at the time of liver implanted to the recipient; up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of MS's detachment | the frequency of MS's detachment from the vasculature and basin wall. | measured at the time of the end of preparation HVC; up to 1 hour |