Back to resultsA Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap
Primary Purpose
Portal Hypertension
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
3d roadmap guidance
conventional TIPS procedure
Sponsored by
About this trial
This is an interventional treatment trial for Portal Hypertension
Eligibility Criteria
Inclusion Criteria:
cirrhosis complications of portal hypertension requiring TIPS
Exclusion Criteria:
non-cirrhotic portal hypertension complete occlusion of intrahepatic portal vein gastro-renal shunt presence of liver tumor pregnancy other contradictions of TIPS
Sites / Locations
- West China Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
3D roadmap
conventional TIPS
Arm Description
TIPS was established using 3d roadmap guidance
conventional TIPS procedure using wedged hepatic venography
Outcomes
Primary Outcome Measures
Technical success rate
number of patients who have received TIPS creation technically successfully
number of punctures
number of intrahepatic punctures for TIPS creation
Secondary Outcome Measures
radiographic fluoroscopy time for portal vein entry
duration of radiographic fluoroscopy for portal vein entry
radiographic fluoroscopy time for the whole procedure
duration of radiographic fluoroscopy for the whole procedure
procedural time
procedural time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03031366
Brief Title
A Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap
Official Title
A Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 13, 2017 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
May 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
Model Description
TIPS creation using real-time 3D roadmap
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3D roadmap
Arm Type
Experimental
Arm Description
TIPS was established using 3d roadmap guidance
Arm Title
conventional TIPS
Arm Type
Active Comparator
Arm Description
conventional TIPS procedure using wedged hepatic venography
Intervention Type
Other
Intervention Name(s)
3d roadmap guidance
Intervention Description
TIPS was established using 3d roadmap
Intervention Type
Other
Intervention Name(s)
conventional TIPS procedure
Intervention Description
conventional TIPS procedure using wedged hepatic venography
Primary Outcome Measure Information:
Title
Technical success rate
Description
number of patients who have received TIPS creation technically successfully
Time Frame
1 month
Title
number of punctures
Description
number of intrahepatic punctures for TIPS creation
Time Frame
1 month
Secondary Outcome Measure Information:
Title
radiographic fluoroscopy time for portal vein entry
Description
duration of radiographic fluoroscopy for portal vein entry
Time Frame
1 month
Title
radiographic fluoroscopy time for the whole procedure
Description
duration of radiographic fluoroscopy for the whole procedure
Time Frame
1 month
Title
procedural time
Description
procedural time
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
cirrhosis complications of portal hypertension requiring TIPS
Exclusion Criteria:
non-cirrhotic portal hypertension complete occlusion of intrahepatic portal vein gastro-renal shunt presence of liver tumor pregnancy other contradictions of TIPS
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap
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