Clinical Course of Cirrhotic Patients With Portal Vein Thrombosis Treated With TIPS
Follow-up and Survival of Cirrhotic and Non Cirrhotic Patients With Portal Vein Thrombosis Treated With Transjugular Intrahepatic Portosystemic Shunt
1 other identifier
observational
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 23, 2017
CompletedFirst Posted
Study publicly available on registry
January 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedMarch 2, 2020
February 1, 2020
5.3 years
January 23, 2017
February 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Outcome of TIPS for PVT in patients with and without cirrhosis
Clinical evolution after placement of TIPS
5 years
Interventions
Eligibility Criteria
Patients with portal vein thrombosis and with or without liver cirrhosis
You may qualify if:
- Written informed consent
- Liver cirrosis or non-cirrhotic patients
- Portal vein thrombosis (degree of vessel obstruction \> 50%)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14000, Mexico
Biospecimen
3 capillary blood tubes of 4.0 ml Inflammation cytokines will be analyzed (IL-1, IL-6, FNTa)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aldo Torre Delgadillo
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran
- PRINCIPAL INVESTIGATOR
Aldo Torre Delgadillo
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 23, 2017
First Posted
January 26, 2017
Study Start
January 1, 2017
Primary Completion
April 30, 2022
Study Completion
June 30, 2023
Last Updated
March 2, 2020
Record last verified: 2020-02