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Using Covered Stent of Diameter of 7mm in TIPS

Primary Purpose

Liver Disease

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
the stent of diameter of 7mm
the stent of diameter of 8mm
Sponsored by
Beijing Shijitan Hospital, Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Disease focused on measuring transjugular intrahepatic portosystemic shunt

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. there is a clear TIPS treatment indications of liver cirrhosis portal hypertension patients of gastrointestinal bleeding.
  2. undergoing elective TIPS to treat patients.
  3. aged 18-70 years old

Exclusion Criteria:

  1. preoperative patients with hepatic encephalopathy.
  2. with portal vein thrombosis patients.
  3. combined liver malignant tumor or other parts of the patients with malignant tumor.
  4. In combination of peptic ulcer bleeding.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    the stent of diameter of 7mm

    the stent of diameter of 8mm

    Arm Description

    Procedure/Surgery:Jugular vein puncture and catheterization. Device:RUPS-100(COOK Company)sheath ,7mm balloon,Pigtail catheter,the stent of diameter of 7mm (Bard,Fluency) Drug(including placebo):No Biological/Vaccine:No

    Procedure/Surgery:Jugular vein puncture and catheterization. Device:RUPS-100(COOK Company)sheath ,8mm balloon,Pigtail catheter,the stent of diameter of 8mm (Bard,Fluency) Drug(including placebo):No Biological/Vaccine:No

    Outcomes

    Primary Outcome Measures

    The incidence of hepatic encephalopathy after TIPS
    The incidence of hepatic encephalopathy after TIPS in 7day,1,3,6,12month

    Secondary Outcome Measures

    the incidence of shunt restenosis after TIPS
    The incidence of shunt restenosis after TIPS in 7day,1,3,6,12month
    the recurrence rate of gastrointestinal bleeding after TIPS
    The recurrence rate of gastrointestinal bleeding after TIPS in 7day,1,3,6,12month
    Portal venous pressure before and afterTIPS
    Portal venous pressure before and afterTIPS.
    liver function in different periods
    liver function during different periods before and after TIPS in 7day,1,3,6,12month
    blood ammonia in different periods
    blood ammonia before and after TIPS in 7day,1,3,6,12month
    jaundice index in different periods
    jaundice index before and after TIPS in 7day,1,3,6,12month
    platelet count in different periods
    platelet count before and after TIPS in 7day,1,3,6,12month

    Full Information

    First Posted
    September 3, 2015
    Last Updated
    September 3, 2015
    Sponsor
    Beijing Shijitan Hospital, Capital Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02541825
    Brief Title
    Using Covered Stent of Diameter of 7mm in TIPS
    Official Title
    Using Covered Stent of Diameter of 7mm in a Prospective, Single Blind, Randomized, Controlled Study of TIPS(Transjugular Intrahepatic Portosystemic Stent Shunt )
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beijing Shijitan Hospital, Capital Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study evaluates the incidence of hepatic encephalopathy between covered stent of diameter of 7mm and 8mm in TIPS(transjugular intrahepatic portosystemic stent shunt ).Half of the participants will receive stent of diameter of 7mm ,while the other half will receive stent of diameter of 8mm.
    Detailed Description
    TIPS is effective in the treatment of hemorrhage of digestive tract and intractable ascites,which are the complications of cirrhosis. At present, the high incidence of hepatic encephalopathy has been a major problem after TIPS. The high incidence rate of hepatic encephalopathy was closly associated with the diameter of the stent. We often use the stent of diameter 8mm in TIPS.In this study, we try to use the stent of smaller diameter of 7mm in TIPS,and compare the incidence of hepatic encephalopathy between the stent of diameter of 7mm and 8mm .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Disease
    Keywords
    transjugular intrahepatic portosystemic shunt

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    216 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    the stent of diameter of 7mm
    Arm Type
    Experimental
    Arm Description
    Procedure/Surgery:Jugular vein puncture and catheterization. Device:RUPS-100(COOK Company)sheath ,7mm balloon,Pigtail catheter,the stent of diameter of 7mm (Bard,Fluency) Drug(including placebo):No Biological/Vaccine:No
    Arm Title
    the stent of diameter of 8mm
    Arm Type
    Other
    Arm Description
    Procedure/Surgery:Jugular vein puncture and catheterization. Device:RUPS-100(COOK Company)sheath ,8mm balloon,Pigtail catheter,the stent of diameter of 8mm (Bard,Fluency) Drug(including placebo):No Biological/Vaccine:No
    Intervention Type
    Device
    Intervention Name(s)
    the stent of diameter of 7mm
    Intervention Description
    108 patients use the stent of diameter of 7mm in TIPS
    Intervention Type
    Device
    Intervention Name(s)
    the stent of diameter of 8mm
    Intervention Description
    108 patients use the stent of diameter of 8mm in TIPS
    Primary Outcome Measure Information:
    Title
    The incidence of hepatic encephalopathy after TIPS
    Description
    The incidence of hepatic encephalopathy after TIPS in 7day,1,3,6,12month
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    the incidence of shunt restenosis after TIPS
    Description
    The incidence of shunt restenosis after TIPS in 7day,1,3,6,12month
    Time Frame
    1 year
    Title
    the recurrence rate of gastrointestinal bleeding after TIPS
    Description
    The recurrence rate of gastrointestinal bleeding after TIPS in 7day,1,3,6,12month
    Time Frame
    1 year
    Title
    Portal venous pressure before and afterTIPS
    Description
    Portal venous pressure before and afterTIPS.
    Time Frame
    1 year
    Title
    liver function in different periods
    Description
    liver function during different periods before and after TIPS in 7day,1,3,6,12month
    Time Frame
    1 year
    Title
    blood ammonia in different periods
    Description
    blood ammonia before and after TIPS in 7day,1,3,6,12month
    Time Frame
    1 year
    Title
    jaundice index in different periods
    Description
    jaundice index before and after TIPS in 7day,1,3,6,12month
    Time Frame
    1 year
    Title
    platelet count in different periods
    Description
    platelet count before and after TIPS in 7day,1,3,6,12month
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: there is a clear TIPS treatment indications of liver cirrhosis portal hypertension patients of gastrointestinal bleeding. undergoing elective TIPS to treat patients. aged 18-70 years old Exclusion Criteria: preoperative patients with hepatic encephalopathy. with portal vein thrombosis patients. combined liver malignant tumor or other parts of the patients with malignant tumor. In combination of peptic ulcer bleeding.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jianli Xu, MD PhD
    Organizational Affiliation
    Beijing Shijitan Hospital of Capital Medical University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Using Covered Stent of Diameter of 7mm in TIPS

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