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

• Conditions: Portal Vein Thrombosis

• Registration Number: NCT03031717
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-26
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-03-02
• Primary Completion: 2022-04-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome of TIPS for PVT in patients with and without cirrhosis	5 years	Clinical evolution after placement of TIPS

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; 🇲🇽 Mexico City, Mexico