Study on The Precise Selection of Stent Diameter for Portal Hypertension Patients With Transjugular Intrahepatic Portosystemic Shunt Based on Computational Fluid Dynamics
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Accuracy of vsPPG
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Accuracy of vsPPG
时间窗: 1 day
To assess the accuracy of vsPPG at the clinical level(virtual PPG values and real PPG value)
次要结局
- Guiding value of vsPPG(1 day)