Magnetic Spiderman for Preparation of Liver Donation

NCT04182256 | Completed

• 1 other identifier: XJYFY-2017ZD1-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplant; Complications; Surgical Injury

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Frequency of MS's detachment

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

Study Arms (2)

MS group

EXPERIMENTAL

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

MA group

NO INTERVENTION

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

Interventions

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.

MS group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• all patients receiving donation after cardiac death in the First Affiliated Hospital, School of Medicine, Xi'an Jiaotong University.

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian JiaotongUniversity

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Intraoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 2, 2019
• Study Start: October 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)