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

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ClinicalTrials.gov Identifier: NCT03031717
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
ALDO TORRE DELGADILLO, 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.


Condition or disease Intervention/treatment
Portal Vein Thrombosis 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.

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Study Type : Observational
Estimated 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 : January 1, 2017
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Outcome of TIPS for PVT in patients with and without cirrhosis [ Time Frame: 5 years ]
    Clinical evolution after placement of TIPS


Biospecimen Retention:   Samples With DNA
3 capillary blood tubes of 4.0 ml Inflammation cytokines will be analyzed (IL-1, IL-6, FNTa)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with portal vein thrombosis and with or without liver cirrhosis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031717


Contacts
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Contact: Aldo Torre 54870900 detoal@yahoo.com
Contact: Aldo Torre Delgadillo detoal@yahoo.mx

Locations
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Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Recruiting
Mexico City, Mexico, 14000
Contact: Aldo Torre Delgadillo, M.D. M.Sc    54870900 ext 2711    detoal@yahoo.com   
Principal Investigator: Aldo Torre-Delgadillo, MD         
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
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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
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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: January 26, 2017    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases