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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-13

Study Completion Date

2017-05-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Portal Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

TIPS creation using real-time 3D roadmap

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3D roadmap

TIPS was established using 3d roadmap guidance

Group Type EXPERIMENTAL

3d roadmap guidance

Intervention Type OTHER

TIPS was established using 3d roadmap

conventional TIPS

conventional TIPS procedure using wedged hepatic venography

Group Type ACTIVE_COMPARATOR

conventional TIPS procedure

Intervention Type OTHER

conventional TIPS procedure using wedged hepatic venography

Interventions

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3d roadmap guidance

TIPS was established using 3d roadmap

Intervention Type OTHER

conventional TIPS procedure

conventional TIPS procedure using wedged hepatic venography

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No