A Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap

Study Overview
=================
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.

Official Title
-----------------
A Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap

Conditions
-----------------
Portal Hypertension

Intervention / Treatment
-----------------
* Other: 3d roadmap guidance
* Other: conventional TIPS procedure


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: TIPS creation using real-time 3D roadmap
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D roadmap<br>TIPS was established using 3d roadmap guidance | Other: 3d roadmap guidance<br>* TIPS was established using 3d roadmap<br>|
| Active Comparator: conventional TIPS<br>conventional TIPS procedure using wedged hepatic venography | Other: conventional TIPS procedure<br>* conventional TIPS procedure using wedged hepatic venography<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate | number of patients who have received TIPS creation technically successfully | 1 month | 
| number of punctures | number of intrahepatic punctures for TIPS creation | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiographic fluoroscopy time for portal vein entry | duration of radiographic fluoroscopy for portal vein entry | 1 month | 
| radiographic fluoroscopy time for the whole procedure | duration of radiographic fluoroscopy for the whole procedure | 1 month | 
| procedural time | procedural time | 1 month |