Skip to content

Magnetic Spiderman for Preparation of Liver Donation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04182256
Acronym
MSPLD
Enrollment
20
Registered
2019-12-02
Start date
2020-10-01
Completion date
2021-03-01
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplant; Complications, Surgical Injury

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.

Interventions

DEVICEMS

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.

Sponsors

First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The number of damaged points on HVCmeasured at the time of the end of preparation HVC; up to 1 hourthe number of damaged points on the HVC during the preparation
Operation timemeasured at the time of the end of preparation HVC; up to 1 houroperation time of preparation of HVC
The number of assistantsmeasured at the time of the end of preparation HVC; up to 1 hourthe number of assistants ensuring smooth operation according to attending's requirement
Leak testmeasured at the time of the end of preparation HVC; up to 1 hourwe 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 hemorrhagemeasured at the time of liver implanted to the recipient; up to 1 hourWhether HVC hemorrhage after implantation

Secondary

MeasureTime frameDescription
Frequency of MS's detachmentmeasured at the time of the end of preparation HVC; up to 1 hourthe frequency of MS's detachment from the vasculature and basin wall.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026