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

Portal Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04421118
• Other study ID #: HEPIC2002
• Status: Enrolling by invitation
• Start date: June 11, 2021
• Est. completion date: December 20, 2024

Study information

• Verified date: February 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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.

Related Conditions & MeSH terms

• Compensated Advanced Chronic Liver Disease
• Hypertension
• Hypertension, Portal
• Liver Diseases
• Portal Hypertension

Intervention

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

Locations

Country	Name	City	State
China	First Affiliated Hospital of Zhejiang University	Hangzhou

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University	LanZhou University

Country where clinical trial is conducted

China, 

References & Publications (7)

de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available. — View Citation

Estes C, Anstee QM, Arias-Loste MT, Bantel H, Bellentani S, Caballeria J, Colombo M, Craxi A, Crespo J, Day CP, Eguchi Y, Geier A, Kondili LA, Kroy DC, Lazarus JV, Loomba R, Manns MP, Marchesini G, Nakajima A, Negro F, Petta S, Ratziu V, Romero-Gomez M, Sanyal A, Schattenberg JM, Tacke F, Tanaka J, Trautwein C, Wei L, Zeuzem S, Razavi H. Modeling NAFLD disease burden in China, France, Germany, Italy, Japan, Spain, United Kingdom, and United States for the period 2016-2030. J Hepatol. 2018 Oct;69(4):896-904. doi: 10.1016/j.jhep.2018.05.036. Epub 2018 Jun 8. — View Citation

Mokdad AA, Lopez AD, Shahraz S, Lozano R, Mokdad AH, Stanaway J, Murray CJ, Naghavi M. Liver cirrhosis mortality in 187 countries between 1980 and 2010: a systematic analysis. BMC Med. 2014 Sep 18;12:145. doi: 10.1186/s12916-014-0145-y. — View Citation

Qi X, An W, Liu F, Qi R, Wang L, Liu Y, Liu C, Xiang Y, Hui J, Liu Z, Qi X, Liu C, Peng B, Ding H, Yang Y, He X, Hou J, Tian J, Li Z. Virtual Hepatic Venous Pressure Gradient with CT Angiography (CHESS 1601): A Prospective Multicenter Study for the Noninvasive Diagnosis of Portal Hypertension. Radiology. 2019 Feb;290(2):370-377. doi: 10.1148/radiol.2018180425. Epub 2018 Nov 20. — View Citation

Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2. — View Citation

Qi X, Li Z, Huang J, Zhu Y, Liu H, Zhou F, Liu C, Xiao C, Dong J, Zhao Y, Xu M, Xing S, Xu W, Yang C. Virtual portal pressure gradient from anatomic CT angiography. Gut. 2015 Jun;64(6):1004-5. doi: 10.1136/gutjnl-2014-308543. Epub 2014 Nov 14. No abstract available. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of vsPPG	To assess the accuracy of vsPPG at the clinical level(virtual PPG values and real PPG value)	1 day
Secondary	Guiding value of vsPPG	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)	1 day