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Magnetic Spiderman for Preparation of Liver Donation (MSPLD)

Primary Purpose

Liver Transplant; Complications, Surgical Injury

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MS
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Transplant; Complications

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • First Affiliated Hospital of Xian JiaotongUniversity

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MS group

MA group

Arm Description

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.

In MA group, assistants use vessel forceps to pull the HVC according to the attending's requirements.

Outcomes

Primary Outcome Measures

The number of damaged points on HVC
the number of damaged points on the HVC during the preparation
Operation time
operation time of preparation of HVC
The number of assistants
the number of assistants ensuring smooth operation according to attending's requirement
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.
HVC hemorrhage
Whether HVC hemorrhage after implantation

Secondary Outcome Measures

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

Full Information

First Posted
November 25, 2019
Last Updated
August 24, 2021
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT04182256
Brief Title
Magnetic Spiderman for Preparation of Liver Donation
Acronym
MSPLD
Official Title
A Prospective Study: Magnetic Spiderman for Preparation of Donor Livers' Inferior Vena Cava
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplant; Complications, Surgical Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MS group
Arm Type
Experimental
Arm Description
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.
Arm Title
MA group
Arm Type
No Intervention
Arm Description
In MA group, assistants use vessel forceps to pull the HVC according to the attending's requirements.
Intervention Type
Device
Intervention Name(s)
MS
Intervention Description
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 Outcome Measure Information:
Title
The number of damaged points on HVC
Description
the number of damaged points on the HVC during the preparation
Time Frame
measured at the time of the end of preparation HVC; up to 1 hour
Title
Operation time
Description
operation time of preparation of HVC
Time Frame
measured at the time of the end of preparation HVC; up to 1 hour
Title
The number of assistants
Description
the number of assistants ensuring smooth operation according to attending's requirement
Time Frame
measured at the time of the end of preparation HVC; up to 1 hour
Title
Leak test
Description
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.
Time Frame
measured at the time of the end of preparation HVC; up to 1 hour
Title
HVC hemorrhage
Description
Whether HVC hemorrhage after implantation
Time Frame
measured at the time of liver implanted to the recipient; up to 1 hour
Secondary Outcome Measure Information:
Title
Frequency of MS's detachment
Description
the frequency of MS's detachment from the vasculature and basin wall.
Time Frame
measured at the time of the end of preparation HVC; up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
First Affiliated Hospital of Xian JiaotongUniversity
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Magnetic Spiderman for Preparation of Liver Donation

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