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

Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Other)
Overall Status
Recruiting
CT.gov ID
NCT03031717
Collaborator
(none)
15
Enrollment
1
Location
77.9
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transjugular intrahepatic portosystemic shunt

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 Design

Study Type:
Observational
Anticipated Enrollment :
15 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Follow-up and Survival of Cirrhotic and Non Cirrhotic Patients With Portal Vein Thrombosis Treated With Transjugular Intrahepatic Portosystemic Shunt
Actual Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Outcome Measures

Primary Outcome Measures

  1. Outcome of TIPS for PVT in patients with and without cirrhosis [5 years]

    Clinical evolution after placement of TIPS

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City Mexico 14000

Sponsors and Collaborators

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ALDO TORRE DELGADILLO, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT03031717
Other Study ID Numbers:
  • TIPS-NEOPORTA
First Posted:
Jan 26, 2017
Last Update Posted:
Mar 2, 2020
Last Verified:
Feb 1, 2020
Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis

Study Results

No Results Posted as of Mar 2, 2020