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Outcome After TIPS

Retrospective Analysis of Outcome After Implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03459378
Enrollment
158
Registered
2018-03-08
Start date
2018-03-23
Completion date
2020-05-14
Last updated
2020-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ascites Hepatic, Hypertension, Portal, Liver Cirrhosis, Variceal Hemorrhage

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.

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.

Interventions

OTHERno intervention - retrospective analyses

retrospective data examination, there are no study related interventions

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
transplantation free survivalfrom date of TIPS until the event, up to 4 yearsSurvival without liver Transplantation in days

Secondary

MeasureTime frameDescription
occurrence of hepatic encephalopathyfrom date of TIPS until the event, up to 4 yearstime to occurrence of the first episode of hepatic encephalopathy in days
occurrence of ascitesfrom date of TIPS until the event, up to 4 yearstime to (re)occurrence of ascites in days

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026