<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04421118</url>
  </required_header>
  <id_info>
    <org_study_id>HEPIC2002</org_study_id>
    <nct_id>NCT04421118</nct_id>
  </id_info>
  <brief_title>The Precise Selection of Stent Diameter for Portal Hypertension Patients With TIPS</brief_title>
  <official_title>Study on The Precise Selection of Stent Diameter for Portal Hypertension Patients With Transjugular Intrahepatic Portosystemic Shunt Based on Computational Fluid Dynamics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>LanZhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>First Affiliated Hospital of Zhejiang University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The precise planning of TIPS, especially individual selection of stent diameter, is a hot and&#xD;
      difficult topic in the field. We have successfully developed a non-invasive technology to&#xD;
      evaluate hepatic venous pressure gradient and portal pressure gradient based on&#xD;
      three-dimensional modeling and fluid dynamics simulation. We propose the concept of virtual&#xD;
      stent-based portal pressure gradient for the first time. With invasive pressure as reference,&#xD;
      the accuracy of virtual stent-based portal pressure gradient will be evaluated in levels of&#xD;
      animal experiments and clinical trials. The predictive value of virtual stent-based portal&#xD;
      pressure gradient for individualized selection of TIPS stent diameter will be further&#xD;
      assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Transjugular intrahepatic portosystemic shunt (TIPS) is an effective treatment for portal&#xD;
      hypertension related variceal bleeding. The precise planning of TIPS, especially individual&#xD;
      selection of stent diameter, is a hot and difficult topic in the field. A stent with smaller&#xD;
      diameter cannot effectively reduce portal pressure, and a stent with larger diameter might&#xD;
      cause hepatic encephalopathy resulted from excessive blood shunt. Therefore, individualized&#xD;
      selection of TIPS stent diameter closely correlates with intervention effect and clinical&#xD;
      outcomes. In our previous study, we have successfully developed a non-invasive technology to&#xD;
      evaluate hepatic venous pressure gradient and portal pressure gradient based on&#xD;
      three-dimensional modeling and fluid dynamics simulation. In this project, we propose the&#xD;
      concept of virtual stent-based portal pressure gradient for the first time. Accurate&#xD;
      three-dimensional models of hepatic-portal vein system with stents of different diameters&#xD;
      will be reconstructed using imaging control and modeling software. In addition, a standard&#xD;
      procedure of fluid dynamics simulation will be fixed with the platform of finite element&#xD;
      calculation. With invasive pressure as reference, the accuracy of virtual stent-based portal&#xD;
      pressure gradient will be evaluated in levels of animal experiments and clinical trials.&#xD;
      Lastly, the predictive value of virtual stent-based portal pressure gradient for&#xD;
      individualized selection of TIPS stent diameter will be further assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">June 11, 2021</start_date>
  <completion_date type="Anticipated">December 20, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of vsPPG</measure>
    <time_frame>1 day</time_frame>
    <description>To assess the accuracy of vsPPG at the clinical level(virtual PPG values and real PPG value)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Guiding value of vsPPG</measure>
    <time_frame>1 day</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Compensated Advanced Chronic Liver Disease</condition>
  <condition>Portal Hypertension</condition>
  <arm_group>
    <arm_group_label>standard portal pressure gradient measurement and CT scan</arm_group_label>
    <description>Procedure/Surgery:&#xD;
Portal pressure gradient measurement and CT imaging examination. Three-dimensional models reconstructing and fluid dynamics simulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>a non-invasive technology to evaluate hepatic venous pressure gradient and portal pressure gradient</intervention_name>
    <description>a non-invasive technology to evaluate hepatic venous pressure gradient and portal pressure gradient based on three-dimensional modeling and fluid dynamics simulation</description>
    <arm_group_label>standard portal pressure gradient measurement and CT scan</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with compensated advanced chronic liver disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Criteria: Inclusion Criteria:&#xD;
&#xD;
          -  age 18-75 years;&#xD;
&#xD;
          -  high-risk treatment failure (e.g.Child-Pugh C or B grade with variceal bleeding);&#xD;
&#xD;
          -  conventional drugs and endoscopic treatment of esophageal variceal bleeding are not&#xD;
             good;&#xD;
&#xD;
          -  End-stage liver disease with variceal bleeding before liver transplantation;&#xD;
&#xD;
          -  successful implementation of TIPS;&#xD;
&#xD;
          -  good compliance with the requirements formulated by the study;&#xD;
&#xD;
          -  with written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Liver transplantation in the past or planning liver transplantation in the 6 months;&#xD;
&#xD;
          -  Common TIPS contraindications (e.g.NYHA level 2 of congestive heart failure ,history&#xD;
             of pulmonary hypertension, portal vein trunk thrombosis, multiple liver cysts,or&#xD;
             intrahepatic bile duct dilatation);&#xD;
&#xD;
          -  severe liver dysfunction: prothrombin activity &lt;40% or bilirubin&gt; 50μmol / L or&#xD;
             Child-Pugh score&gt; 12;&#xD;
&#xD;
          -  history of hepatic encephalopathy;&#xD;
&#xD;
          -  serum creatinine&gt; 133μmol / L;&#xD;
&#xD;
          -  severe hyponatremia (blood sodium &lt;125mmol / L);&#xD;
&#xD;
          -  uncontrollable infections;&#xD;
&#xD;
          -  allergic to intravenous contrast agent;&#xD;
&#xD;
          -  subject refused to participate in the trial or without the ability to participate in&#xD;
             informed consent;&#xD;
&#xD;
          -  previous history of TIPS treatment;&#xD;
&#xD;
          -  any comorbidities or conditions that affect the test results as judged by the&#xD;
             investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jun-hui Sun, MD,PH.D</last_name>
    <role>Study Director</role>
    <affiliation>First Affiliated Hospital of Zhejiang University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>First Affiliated Hospital of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>30215362</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25398771</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>30457484</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26047908</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25242656</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>29886156</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>30940552</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>February 14, 2023</last_update_submitted>
  <last_update_submitted_qc>February 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Transjugular intrahepatic portosystemic shunt</keyword>
  <keyword>Stent selection</keyword>
  <keyword>Fluid dynamics simulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Hypertension, Portal</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04421118
org study id: HEPIC2002
nct id: NCT04421118
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Accuracy of vsPPG
time frame: 1 day
description: To assess the accuracy of vsPPG at the clinical level(virtual PPG values and real PPG value)
measure: Guiding value of vsPPG
time frame: 1 day
description: 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)
arm group label: standard portal pressure gradient measurement and CT scan
description: Procedure/Surgery:
Portal pressure gradient measurement and CT imaging examination. Three-dimensional models reconstructing and fluid dynamics simulation.
intervention type: Other
intervention name: a non-invasive technology to evaluate hepatic venous pressure gradient and portal pressure gradient
description: a non-invasive technology to evaluate hepatic venous pressure gradient and portal pressure gradient based on three-dimensional modeling and fluid dynamics simulation
arm group label: standard portal pressure gradient measurement and CT scan
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jun-hui Sun, MD,PH.D
role: Study Director
affiliation: First Affiliated Hospital of Zhejiang University
facility: 
country: China
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.
PMID: 30215362
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.
PMID: 25398771
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.
PMID: 30457484
citation: 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: 26047908
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.
PMID: 25242656
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.
PMID: 29886156
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.
PMID: 30940552
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Hypertension, Portal
mesh term: Hypertension
sharing ipd: Undecided