Magnetic Spiderman for Preparation of Liver Donation

Liver Transplant; Complications Clinical Trial

— MSPLD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04182256
• Other study ID #: XJYFY-2017ZD1-01
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: August 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Intraoperative Complications
• Liver Transplant; Complications
• Surgical Injury

Intervention

Device:
• MS
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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian JiaotongUniversity	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Operation time	operation time of preparation of HVC	measured at the time of the end of preparation HVC; up to 1 hour
Primary	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
Primary	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
Primary	HVC hemorrhage	Whether HVC hemorrhage after implantation	measured at the time of liver implanted to the recipient; up to 1 hour
Secondary	Frequency of MS's detachment	the frequency of MS's detachment from the vasculature and basin wall.	measured at the time of the end of preparation HVC; up to 1 hour