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

• Conditions: Portal Hypertension; Compensated Advanced Chronic Liver Disease
• Interventions: Other: a non-invasive technology to evaluate hepatic venous pressure gradient and portal pressure gradient

• Registration Number: NCT04421118
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief 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.

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Study Start: 2021-06-11
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16
• Primary Completion: 2023-12-20
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• age 18-75 years;
• high-risk treatment failure (e.g.Child-Pugh C or B grade with variceal bleeding);
• conventional drugs and endoscopic treatment of esophageal variceal bleeding are not good;
• End-stage liver disease with variceal bleeding before liver transplantation;
• successful implementation of TIPS;
• good compliance with the requirements formulated by the study;
• with written informed consent.

Exclusion Criteria

• Liver transplantation in the past or planning liver transplantation in the 6 months;
• Common TIPS contraindications (e.g.NYHA level 2 of congestive heart failure ,history of pulmonary hypertension, portal vein trunk thrombosis, multiple liver cysts,or intrahepatic bile duct dilatation);
• severe liver dysfunction: prothrombin activity <40% or bilirubin> 50μmol / L or Child-Pugh score> 12;
• history of hepatic encephalopathy;
• serum creatinine> 133μmol / L;
• severe hyponatremia (blood sodium <125mmol / L);
• uncontrollable infections;
• allergic to intravenous contrast agent;
• subject refused to participate in the trial or without the ability to participate in informed consent;
• previous history of TIPS treatment;
• any comorbidities or conditions that affect the test results as judged by the investigator.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
standard portal pressure gradient measurement and CT scan	a non-invasive technology to evaluate hepatic venous pressure gradient and portal pressure gradient	Procedure/Surgery: Portal pressure gradient measurement and CT imaging examination. Three-dimensional models reconstructing and fluid dynamics simulation.

Primary Outcome Measures

Name	Time	Method
Accuracy of vsPPG	1 day	To assess the accuracy of vsPPG at the clinical level(virtual PPG values and real PPG value)

Secondary Outcome Measures

Name	Time	Method
Guiding value of vsPPG	1 day	To assess the Guiding value of vsPPG at the level of animal experiments(the predictive value of virtual stent-based portal pressure gradient for individualized selection of TIPS stent diameter)

Trial Locations

Locations (1)

First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, China