<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/NCT03031717</url>
  </required_header>
  <id_info>
    <org_study_id>TIPS-NEOPORTA</org_study_id>
    <nct_id>NCT03031717</nct_id>
  </id_info>
  <brief_title>Clinical Course of Cirrhotic Patients With Portal Vein Thrombosis Treated With TIPS</brief_title>
  <official_title>Follow-up and Survival of Cirrhotic and Non Cirrhotic Patients With Portal Vein Thrombosis Treated With Transjugular Intrahepatic Portosystemic Shunt</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</source>
  <brief_summary>
    <textblock>
      Portal vein thrombosis (PVT) is defined as an obstruction of the portal vein. The prevalence&#xD;
      of PVT is 10-25% and incidence is about 16% in cirrhotic patients. PVT leads to increased&#xD;
      intrahepatic resistance, decreased portal velocities, splanchnic vasodilatation, and stagnant&#xD;
      flow.&#xD;
&#xD;
      Portal vein recanalization (PVR) with transjugular intrahepatic portosystemic shunt (TIPS) is&#xD;
      aimed at restoring main portal vein (PV) flow in chronic PVT. In this study, we will review&#xD;
      the safety and outcomes of this approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Portal vein thrombosis (PVT) is a fairly common complication of liver cirrhosis. Importantly,&#xD;
      occlusive PVT might influence the prognosis of patients with cirrhosis. Transjugular&#xD;
      intrahepatic portosystemic shunt (TIPS) has been reported to be an effective treatment of PVT&#xD;
      in cirrhosis, with the advantage of avoiding the risk of bleeding linked to anticoagulation.&#xD;
      In this study, we will evaluate the outcome of TIPS for PVT in patients with and without&#xD;
      cirrhosis and determinate survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2022</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Outcome of TIPS for PVT in patients with and without cirrhosis</measure>
    <time_frame>5 years</time_frame>
    <description>Clinical evolution after placement of TIPS</description>
  </primary_outcome>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Portal Vein Thrombosis</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transjugular intrahepatic portosystemic shunt</intervention_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      3 capillary blood tubes of 4.0 ml Inflammation cytokines will be analyzed (IL-1, IL-6, FNTa)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with portal vein thrombosis and with or without liver cirrhosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Liver cirrosis or non-cirrhotic patients&#xD;
&#xD;
          -  Portal vein thrombosis (degree of vessel obstruction &gt; 50%)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active variceal bleeding&#xD;
&#xD;
          -  Prior history of TIPS placement or shunt surgery&#xD;
&#xD;
          -  Concomitant renal insufficiency&#xD;
&#xD;
          -  Severe cardiopulmonary diseases&#xD;
&#xD;
          -  Uncontrolled sepsis Serious medical conditions which may reduce the life expectancy&#xD;
&#xD;
          -  Contraindications for TIPS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aldo Torre Delgadillo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aldo Torre Delgadillo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aldo Torre</last_name>
    <phone>54870900</phone>
    <email>detoal@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Aldo Torre Delgadillo</last_name>
    <email>detoal@yahoo.mx</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</name>
      <address>
        <city>Mexico City</city>
        <zip>14000</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aldo Torre Delgadillo, M.D. M.Sc</last_name>
      <phone>54870900</phone>
      <phone_ext>2711</phone_ext>
      <email>detoal@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Aldo Torre-Delgadillo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>February 27, 2020</last_update_submitted>
  <last_update_submitted_qc>February 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</investigator_affiliation>
    <investigator_full_name>ALDO TORRE DELGADILLO</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03031717
org study id: TIPS-NEOPORTA
nct id: NCT03031717
lead sponsor: 
Portal vein thrombosis (PVT) is defined as an obstruction of the portal vein. The prevalence
      of PVT is 10-25% and incidence is about 16% in cirrhotic patients. PVT leads to increased
      intrahepatic resistance, decreased portal velocities, splanchnic vasodilatation, and stagnant
      flow.

      Portal vein recanalization (PVR) with transjugular intrahepatic portosystemic shunt (TIPS) is
      aimed at restoring main portal vein (PV) flow in chronic PVT. In this study, we will review
      the safety and outcomes of this approach.
Portal vein thrombosis (PVT) is a fairly common complication of liver cirrhosis. Importantly,
      occlusive PVT might influence the prognosis of patients with cirrhosis. Transjugular
      intrahepatic portosystemic shunt (TIPS) has been reported to be an effective treatment of PVT
      in cirrhosis, with the advantage of avoiding the risk of bleeding linked to anticoagulation.
      In this study, we will evaluate the outcome of TIPS for PVT in patients with and without
      cirrhosis and determinate survival.
observational model: Cohort
time perspective: Retrospective
measure: Outcome of TIPS for PVT in patients with and without cirrhosis
time frame: 5 years
description: Clinical evolution after placement of TIPS
intervention type: Procedure
intervention name: Transjugular intrahepatic portosystemic shunt
3 capillary blood tubes of 4.0 ml Inflammation cytokines will be analyzed (IL-1, IL-6, FNTa)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Aldo Torre Delgadillo
role: Principal Investigator
affiliation: Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran
last name: Aldo Torre Delgadillo
role: Principal Investigator
affiliation: Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
last name: Aldo Torre
phone: 54870900
email: detoal@yahoo.com
last name: Aldo Torre Delgadillo
email: detoal@yahoo.mx
facility: 
status: Recruiting
contact: 
investigator: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
investigator full name: ALDO TORRE DELGADILLO
investigator title: MD
mesh term: Thrombosis
mesh term: Venous Thrombosis