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Magnetic Spiderman for Preparation of Liver Donation (MSPLD)

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Xi'an Jiaotong University

Status

Completed

Conditions

Liver Transplant; Complications
Surgical Injury

Treatments

Device: MS

Study type

Interventional

Funder types

Other

Identifiers

NCT04182256
XJYFY-2017ZD1-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

MS group
Experimental group
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.
Treatment:
Device: MS
MA group
No Intervention group
Description:
In MA group, assistants use vessel forceps to pull the HVC according to the attending's requirements.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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