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

Portal Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031366
• Other study ID #: 3D roadmap for TIPS
• Status: Completed
• Phase: N/A
• Start date: February 13, 2017
• Est. completion date: May 30, 2017

Study information

• Verified date: January 2019
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension, Portal
• Portal Hypertension

Intervention

Other:
• 3d roadmap guidance
TIPS was established using 3d roadmap
• conventional TIPS procedure
conventional TIPS procedure using wedged hepatic venography

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success rate	number of patients who have received TIPS creation technically successfully	1 month
Primary	number of punctures	number of intrahepatic punctures for TIPS creation	1 month
Secondary	radiographic fluoroscopy time for portal vein entry	duration of radiographic fluoroscopy for portal vein entry	1 month
Secondary	radiographic fluoroscopy time for the whole procedure	duration of radiographic fluoroscopy for the whole procedure	1 month
Secondary	procedural time	procedural time	1 month