NCT04421118

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

June 11, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

2.5 years

First QC Date

June 4, 2020

Last Update Submit

February 14, 2023

Conditions

Compensated Advanced Chronic Liver DiseasePortal Hypertension

Keywords

Transjugular intrahepatic portosystemic shuntStent selectionFluid dynamics simulation

Outcome Measures

Primary Outcomes (1)

  • Accuracy of vsPPG

    To assess the accuracy of vsPPG at the clinical level(virtual PPG values and real PPG value)

    1 day

Secondary Outcomes (1)

  • Guiding value of vsPPG

    1 day

Study Arms (1)

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.

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

Interventions

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

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

standard portal pressure gradient measurement and CT scan

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with compensated advanced chronic liver disease

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Zhejiang University

Hangzhou, China

Location

Related Publications (7)

  • 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.

    PMID: 30215362BACKGROUND

  • 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.

    PMID: 25398771BACKGROUND

  • 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.

    PMID: 30457484BACKGROUND

  • 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.

    PMID: 26047908BACKGROUND

  • 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.

    PMID: 25242656BACKGROUND

  • 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.

    PMID: 29886156BACKGROUND

  • 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.

    PMID: 30940552BACKGROUND

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Jun-hui Sun, MD,PH.D

    First Affiliated Hospital of Zhejiang University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 9, 2020

Study Start

June 11, 2021

Primary Completion

December 20, 2023

Study Completion

December 20, 2024

Last Updated

February 16, 2023

Record last verified: 2023-02

Locations

CN(1)