<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/NCT03031366</url>
  </required_header>
  <id_info>
    <org_study_id>3D roadmap for TIPS</org_study_id>
    <nct_id>NCT03031366</nct_id>
  </id_info>
  <brief_title>A Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap</brief_title>
  <official_title>A Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West China Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      TIPS creation has been widely used to treat the complications associated with portal&#xD;
      hypertension. In association with increased operator experience and the ongoing development&#xD;
      of imaging modalities, the rate of major complications associated with TIPS has decreased&#xD;
      significantly in the past decades. However, the passage of a curved needle from the hepatic&#xD;
      vein into the portal vein still remains a challenging and time-consuming part of the&#xD;
      procedure and is associated with puncture-related complications that are potentially&#xD;
      fatal.Three-dimensional roadmap guidance has been widely applied in various interventions.&#xD;
      The aim of the present study is to prospectively assess the feasibility and efficacy of&#xD;
      real-time 3D roadmap guidance during TIPS creation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2017</start_date>
  <completion_date type="Actual">May 30, 2017</completion_date>
  <primary_completion_date type="Actual">May 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>TIPS creation using real-time 3D roadmap</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Technical success rate</measure>
    <time_frame>1 month</time_frame>
    <description>number of patients who have received TIPS creation technically successfully</description>
  </primary_outcome>
  <primary_outcome>
    <measure>number of punctures</measure>
    <time_frame>1 month</time_frame>
    <description>number of intrahepatic punctures for TIPS creation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>radiographic fluoroscopy time for portal vein entry</measure>
    <time_frame>1 month</time_frame>
    <description>duration of radiographic fluoroscopy for portal vein entry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>radiographic fluoroscopy time for the whole procedure</measure>
    <time_frame>1 month</time_frame>
    <description>duration of radiographic fluoroscopy for the whole procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>procedural time</measure>
    <time_frame>1 month</time_frame>
    <description>procedural time</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Portal Hypertension</condition>
  <arm_group>
    <arm_group_label>3D roadmap</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TIPS was established using 3d roadmap guidance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional TIPS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>conventional TIPS procedure using wedged hepatic venography</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>3d roadmap guidance</intervention_name>
    <description>TIPS was established using 3d roadmap</description>
    <arm_group_label>3D roadmap</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional TIPS procedure</intervention_name>
    <description>conventional TIPS procedure using wedged hepatic venography</description>
    <arm_group_label>conventional TIPS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        cirrhosis complications of portal hypertension requiring TIPS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        non-cirrhotic portal hypertension complete occlusion of intrahepatic portal vein&#xD;
        gastro-renal shunt presence of liver tumor pregnancy other contradictions of 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>
  <location>
    <facility>
      <name>West China Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 21, 2017</study_first_submitted>
  <study_first_submitted_qc>January 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West China Hospital</investigator_affiliation>
    <investigator_full_name>luo xuefeng</investigator_full_name>
    <investigator_title>attending doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Portal</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/NCT03031366
org study id: 3D roadmap for TIPS
nct id: NCT03031366
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
TIPS creation has been widely used to treat the complications associated with portal
      hypertension. In association with increased operator experience and the ongoing development
      of imaging modalities, the rate of major complications associated with TIPS has decreased
      significantly in the past decades. However, the passage of a curved needle from the hepatic
      vein into the portal vein still remains a challenging and time-consuming part of the
      procedure and is associated with puncture-related complications that are potentially
      fatal.Three-dimensional roadmap guidance has been widely applied in various interventions.
      The aim of the present study is to prospectively assess the feasibility and efficacy of
      real-time 3D roadmap guidance during TIPS creation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: TIPS creation using real-time 3D roadmap
primary purpose: Treatment
masking: None (Open Label)
measure: Technical success rate
time frame: 1 month
description: number of patients who have received TIPS creation technically successfully
measure: number of punctures
time frame: 1 month
description: number of intrahepatic punctures for TIPS creation
measure: radiographic fluoroscopy time for portal vein entry
time frame: 1 month
description: duration of radiographic fluoroscopy for portal vein entry
measure: radiographic fluoroscopy time for the whole procedure
time frame: 1 month
description: duration of radiographic fluoroscopy for the whole procedure
measure: procedural time
time frame: 1 month
description: procedural time
arm group label: 3D roadmap
arm group type: Experimental
description: TIPS was established using 3d roadmap guidance
arm group label: conventional TIPS
arm group type: Active Comparator
description: conventional TIPS procedure using wedged hepatic venography
intervention type: Other
intervention name: 3d roadmap guidance
description: TIPS was established using 3d roadmap
arm group label: 3D roadmap
intervention type: Other
intervention name: conventional TIPS procedure
description: conventional TIPS procedure using wedged hepatic venography
arm group label: conventional TIPS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: West China Hospital
investigator full name: luo xuefeng
investigator title: attending doctor
mesh term: Hypertension, Portal
sharing ipd: Undecided