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NCT03031717 Clinical Trial

Clinical Course of Cirrhotic Patients With Portal Vein Thrombosis Treated With TIPS

Portal Vein Thrombosis Clinical Trial

Official title:
Follow-up and Survival of Cirrhotic and Non Cirrhotic Patients With Portal Vein Thrombosis Treated With Transjugular Intrahepatic Portosystemic Shunt

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03031717
Other study ID # TIPS-NEOPORTA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date June 30, 2023

Study information
Verified date February 2020
Source Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Contact Aldo Torre
Phone 54870900
Email detoal@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Portal vein thrombosis (PVT) is defined as an obstruction of the portal vein. The prevalence of PVT is 10-25% and incidence is about 16% in cirrhotic patients. PVT leads to increased intrahepatic resistance, decreased portal velocities, splanchnic vasodilatation, and stagnant flow.

Portal vein recanalization (PVR) with transjugular intrahepatic portosystemic shunt (TIPS) is aimed at restoring main portal vein (PV) flow in chronic PVT. In this study, we will review the safety and outcomes of this approach.

Description:

Portal vein thrombosis (PVT) is a fairly common complication of liver cirrhosis. Importantly, occlusive PVT might influence the prognosis of patients with cirrhosis. Transjugular intrahepatic portosystemic shunt (TIPS) has been reported to be an effective treatment of PVT in cirrhosis, with the advantage of avoiding the risk of bleeding linked to anticoagulation. In this study, we will evaluate the outcome of TIPS for PVT in patients with and without cirrhosis and determinate survival.

Recruitment information / eligibility
Status Recruiting
Enrollment 15
Est. completion date June 30, 2023
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Written informed consent

- Liver cirrosis or non-cirrhotic patients

- Portal vein thrombosis (degree of vessel obstruction > 50%)

Exclusion Criteria:

- Active variceal bleeding

- Prior history of TIPS placement or shunt surgery

- Concomitant renal insufficiency

- Severe cardiopulmonary diseases

- Uncontrolled sepsis Serious medical conditions which may reduce the life expectancy

- Contraindications for TIPS

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Transjugular intrahepatic portosystemic shunt

Locations
Country Name City State
Mexico Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City

Sponsors (1)
Lead Sponsor Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Outcome of TIPS for PVT in patients with and without cirrhosis Clinical evolution after placement of TIPS 5 years
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