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

Not Applicable

Completed

• Conditions: Portal Hypertension
• Interventions: Other: 3d roadmap guidance; Other: conventional TIPS procedure

• Registration Number: NCT03031366
• Lead Sponsor: West China Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-21
• Study First Submitted QC: 2017-01-21
• Study First Posted: 2017-01-25
• Study Start: 2017-02-13
• Primary Completion: 2017-05-30
• Study Completion: 2017-05-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-07
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D roadmap	3d roadmap guidance	TIPS was established using 3d roadmap guidance
conventional TIPS	conventional TIPS procedure	conventional TIPS procedure using wedged hepatic venography

Primary Outcome Measures

Name	Time	Method
Technical success rate	1 month	number of patients who have received TIPS creation technically successfully
number of punctures	1 month	number of intrahepatic punctures for TIPS creation

Secondary Outcome Measures

Name	Time	Method
radiographic fluoroscopy time for portal vein entry	1 month	duration of radiographic fluoroscopy for portal vein entry
radiographic fluoroscopy time for the whole procedure	1 month	duration of radiographic fluoroscopy for the whole procedure
procedural time	1 month	procedural time

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China