Skip to main content
OpenTrials
Completed

NCT Number: NCT03031366

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Portal Hypertension Digestive System Diseases Hypertension, Portal Liver Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3d roadmap guidance

Other

TIPS was established using 3d roadmap

conventional TIPS procedure

Other

conventional TIPS procedure using wedged hepatic venography

Primary outcomes

  1. Technical success rate

    Time frame: 1 month

    number of patients who have received TIPS creation technically successfully

  2. number of punctures

    Time frame: 1 month

    number of intrahepatic punctures for TIPS creation

Secondary outcomes

  1. radiographic fluoroscopy time for portal vein entry

    Time frame: 1 month

    duration of radiographic fluoroscopy for portal vein entry

  2. radiographic fluoroscopy time for the whole procedure

    Time frame: 1 month

    duration of radiographic fluoroscopy for the whole procedure

  3. procedural time

    Time frame: 1 month

    procedural time

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 25, 2017
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.