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

NCT ID: NCT04421118

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-11
• Study Completion Date: 2024-12-20

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.

Conditions

Compensated Advanced Chronic Liver Disease; Portal Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

standard portal pressure gradient measurement and CT scan

Procedure/Surgery:

Portal pressure gradient measurement and CT imaging examination. Three-dimensional models reconstructing and fluid dynamics simulation.

a non-invasive technology to evaluate hepatic venous pressure gradient and portal pressure gradient

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LanZhou University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun-hui Sun, MD,PH.D

Role: STUDY_DIRECTOR

First Affiliated Hospital of Zhejiang University

Locations

First Affiliated Hospital of Zhejiang University

Hangzhou, , China

Countries

China

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Trebicka J, Bastgen D, Byrtus J, Praktiknjo M, Terstiegen S, Meyer C, Thomas D, Fimmers R, Treitl M, Euringer W, Sauerbruch T, Rossle M. Smaller-Diameter Covered Transjugular Intrahepatic Portosystemic Shunt Stents Are Associated With Increased Survival. Clin Gastroenterol Hepatol. 2019 Dec;17(13):2793-2799.e1. doi: 10.1016/j.cgh.2019.03.042. Epub 2019 Mar 30.

Reference Type: BACKGROUND

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Other Identifiers

HEPIC2002

Identifier Type: -

Identifier Source: org_study_id