NCT04421118

The Precise Selection of Stent Diameter for Portal Hypertension Patients With TIPS

Study on The Precise Selection of Stent Diameter for Portal Hypertension Patients With Transjugular Intrahepatic Portosystemic Shunt Based on Computational Fluid Dynamics

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The precise planning of TIPS, especially individual selection of stent diameter, is a hot and difficult topic in the field. We have successfully developed a non-invasive technology to evaluate hepatic venous pressure gradient and portal pressure gradient based on three-dimensional modeling and fluid dynamics simulation. We propose the concept of virtual stent-based portal pressure gradient for the first time. With invasive pressure as reference, the accuracy of virtual stent-based portal pressure gradient will be evaluated in levels of animal experiments and clinical trials. The predictive value of virtual stent-based portal pressure gradient for individualized selection of TIPS stent diameter will be further assessed.

Detailed description

Transjugular intrahepatic portosystemic shunt (TIPS) is an effective treatment for portal hypertension related variceal bleeding. The precise planning of TIPS, especially individual selection of stent diameter, is a hot and difficult topic in the field. A stent with smaller diameter cannot effectively reduce portal pressure, and a stent with larger diameter might cause hepatic encephalopathy resulted from excessive blood shunt. Therefore, individualized selection of TIPS stent diameter closely correlates with intervention effect and clinical outcomes. In our previous study, we have successfully developed a non-invasive technology to evaluate hepatic venous pressure gradient and portal pressure gradient based on three-dimensional modeling and fluid dynamics simulation. In this project, we propose the concept of virtual stent-based portal pressure gradient for the first time. Accurate three-dimensional models of hepatic-portal vein system with stents of different diameters will be reconstructed using imaging control and modeling software. In addition, a standard procedure of fluid dynamics simulation will be fixed with the platform of finite element calculation. With invasive pressure as reference, the accuracy of virtual stent-based portal pressure gradient will be evaluated in levels of animal experiments and clinical trials. Lastly, the predictive value of virtual stent-based portal pressure gradient for individualized selection of TIPS stent diameter will be further assessed.

Conditions

• Compensated Advanced Chronic Liver Disease
• Portal Hypertension

Interventions

Type	Name	Description
OTHER	a non-invasive technology to evaluate hepatic venous pressure gradient and portal pressure gradient	a non-invasive technology to evaluate hepatic venous pressure gradient and portal pressure gradient based on three-dimensional modeling and fluid dynamics simulation

Timeline

• Start date: 2021-06-11
• Primary completion: 2023-12-20
• Completion: 2024-12-20
• First posted: 2020-06-09
• Last updated: 2023-02-16

Locations

1 site across 1 country: China