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Outcome After TIPS

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ClinicalTrials.gov Identifier: NCT03459378
Recruitment Status : Completed
First Posted : March 8, 2018
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Study Description
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Brief Summary:
This clinical trial is a retrospective single-centre study. Research data will be acquired via patient histories stored in the hospital data system. Data of patients who received a Transjugular Intrahepatic Portosystemic Shunt (TIPS) at the University Hospital Graz between 1.1.2004 and 31.12.2017 will be included into the study. The aim is to investigate the outcome (transplantation free survival, time to (re)occurrence of ascites, occurrence of hepatic encephalopathy) of patients with portal hypertension after TIPS.

Condition or disease Intervention/treatment
Hypertension, Portal Liver Cirrhosis Variceal Hemorrhage Ascites Hepatic Other: no intervention - retrospective analyses

Detailed Description:

The implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS) is a valuable measure to reduce portal hypertension and prevent portal hypertension-related complications. It can be used as a symptomatic treatment in patients with chronic portal hypertension as well as for the treatment of active variceal bleedings or large gastrointestinal varices that go along with threatening bleeding danger.

However, this invasive procedure carries a high risk for complications. 30-days mortality after TIPS implantation amounts between 4% and 45%.

A common complication is the (initial) manifestation or deterioration of hepatic encephalopathy, which occurs in 33-46 % after TIPS implantation.

Other complications that are directly related to the intervention are bleeding, infections and stent migration.

Aim of this retrospective single centre study is to investigate the long-term outcome after TIPS implantation with regard to transplantation free survival and time to (re-) occurrence of portal hypertension-related complications, especially ascites and hepatic encephalopathy.

Intervention-related complications as well as long-term effects should be evaluated to facilitate the decision for or against TIPS.

Study Design
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Study Type : Observational
Actual Enrollment : 158 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Analysis of Outcome After Implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Actual Study Start Date : March 23, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : May 14, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: no intervention - retrospective analyses
    retrospective data examination, there are no study related interventions

Outcome Measures
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Primary Outcome Measures :
  1. transplantation free survival [ Time Frame: from date of TIPS until the event, up to 4 years ]
    Survival without liver Transplantation in days


Secondary Outcome Measures :
  1. occurrence of hepatic encephalopathy [ Time Frame: from date of TIPS until the event, up to 4 years ]
    time to occurrence of the first episode of hepatic encephalopathy in days

  2. occurrence of ascites [ Time Frame: from date of TIPS until the event, up to 4 years ]
    time to (re)occurrence of ascites in days


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients at the age of 18-90 years who received a Transjugular Intrahepatic Portosystemic Shunt at the University Hospital of Graz/Austria between 1.1.2004 and 31.12.2017
Criteria

Inclusion Criteria:

  • every person at the age of 18-90 years who received a Transjugular Intrahepatic Portosystemic Shunt at the University Hospital of Graz/Austria between 1.1.2004 and 31.12.2017

Exclusion Criteria:

  • age under 18
Contacts and Locations
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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): NCT03459378


Locations
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Austria
Medical University of Graz
Graz, Austria, 8010
Sponsors and Collaborators
Medical University of Graz
More Information
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT03459378    
Other Study ID Numbers: Retro-TIPS
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Hypertension, Portal
Hemorrhage
Ascites
 Pathologic Processes
Fibrosis
Liver Diseases
Digestive System Diseases