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

Sichuan University

Status: Completed

Conditions: Portal Hypertension

Treatments: Other: conventional TIPS procedure; Other: 3d roadmap guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT03031366

3D roadmap for TIPS

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

3D roadmap

Experimental group

Description:

TIPS was established using 3d roadmap guidance

Treatment:

Other: 3d roadmap guidance

conventional TIPS

Active Comparator group

Description:

conventional TIPS procedure using wedged hepatic venography

Treatment:

Other: conventional TIPS procedure