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3D CT Guidance for Transjugular Intrahepatic Portosystemic Shunt Creation

Primary Purpose

Portal Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CT-image guidance
CO2 portograms guidance
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Portal Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Cirrhosis
  2. Scheduled for indicated TIPS procedure

Exclusion Criteria:

  1. Presence of portal vein thrombosis
  2. Presence of ascites
  3. Presence of hepatic vein occlusion or stenosis
  4. Proven malignancy including hepatocellular carcinoma 5. End-stage renal disease under renal replacement therapy; 6. Cardiorespiratory failure 7. Pregnancy or patients not giving informed consent for TIPS procedures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    CT-image guidance

    CO2 portography

    Arm Description

    Previously acquired portal venous phase of CT datasets and intra-operative CT datasets were registered on a dedicated workstation. The selected volume of interest of the CT-image showing portal vein vasculature was overlaid onto the fluoroscopic display as real-time 3D CT-image guidance during the procedure.

    two two-dimensional (2D) CO2 portograms

    Outcomes

    Primary Outcome Measures

    Technical success rate

    Secondary Outcome Measures

    Median needle passes for portal vein entry
    Median radiographic fluoroscopy time for portal vein entry
    The median radiation dose for the whole TIPS procedure
    The rate of TIPS complication

    Full Information

    First Posted
    June 21, 2015
    Last Updated
    June 23, 2015
    Sponsor
    West China Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02480426
    Brief Title
    3D CT Guidance for Transjugular Intrahepatic Portosystemic Shunt Creation
    Official Title
    Guidance for TIPS Creation: CT-image Versus CO2 Portography
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    December 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    West China Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To prospectively evaluate the efficacy of real-time 3D CT-image guidance and CO2 portography during transjugular intrahepatic portosystemic shunt (TIPS) creation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Portal Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CT-image guidance
    Arm Type
    Experimental
    Arm Description
    Previously acquired portal venous phase of CT datasets and intra-operative CT datasets were registered on a dedicated workstation. The selected volume of interest of the CT-image showing portal vein vasculature was overlaid onto the fluoroscopic display as real-time 3D CT-image guidance during the procedure.
    Arm Title
    CO2 portography
    Arm Type
    Active Comparator
    Arm Description
    two two-dimensional (2D) CO2 portograms
    Intervention Type
    Device
    Intervention Name(s)
    CT-image guidance
    Intervention Description
    TIPS creation is performed under the guidance of 3D CT-image.
    Intervention Type
    Drug
    Intervention Name(s)
    CO2 portograms guidance
    Intervention Description
    TIPS creation is performed under the guidance of two-dimensional (2D) CO2 portograms.
    Primary Outcome Measure Information:
    Title
    Technical success rate
    Time Frame
    procedure
    Secondary Outcome Measure Information:
    Title
    Median needle passes for portal vein entry
    Time Frame
    procedure
    Title
    Median radiographic fluoroscopy time for portal vein entry
    Time Frame
    procedure
    Title
    The median radiation dose for the whole TIPS procedure
    Time Frame
    procedure
    Title
    The rate of TIPS complication
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Cirrhosis Scheduled for indicated TIPS procedure Exclusion Criteria: Presence of portal vein thrombosis Presence of ascites Presence of hepatic vein occlusion or stenosis Proven malignancy including hepatocellular carcinoma 5. End-stage renal disease under renal replacement therapy; 6. Cardiorespiratory failure 7. Pregnancy or patients not giving informed consent for TIPS procedures

    12. IPD Sharing Statement

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    3D CT Guidance for Transjugular Intrahepatic Portosystemic Shunt Creation

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