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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03031366

Enrollment

Registered

2017-01-25

Start date

2017-02-13

Completion date

2017-05-30

Last updated

2019-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Portal Hypertension

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.

Interventions

OTHER3d roadmap guidance

TIPS was established using 3d roadmap

OTHERconventional TIPS procedure

conventional TIPS procedure using wedged hepatic venography

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

TIPS creation using real-time 3D roadmap

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026