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Completed

NCT Number: NCT04182256

Magnetic Spiderman for Preparation of Liver Donation

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.

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Key information

Conditions

Liver Transplant; Complications Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Surgical Injury

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Xian JiaotongUniversity

Xi'an, Shaanxi, 710061, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MS

Device

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.

Primary outcomes

  1. The number of damaged points on HVC

    Time frame: 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

  2. Operation time

    Time frame: measured at the time of the end of preparation HVC; up to 1 hour

    operation time of preparation of HVC

  3. The number of assistants

    Time frame: 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

  4. Leak test

    Time frame: 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.

  5. HVC hemorrhage

    Time frame: measured at the time of liver implanted to the recipient; up to 1 hour

    Whether HVC hemorrhage after implantation

Secondary outcomes

  1. Frequency of MS's detachment

    Time frame: measured at the time of the end of preparation HVC; up to 1 hour

    the frequency of MS's detachment from the vasculature and basin wall.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

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

Acronym: MSPLD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2019
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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