Clinical trial NCT03459378: Outcome After TIPS
Official title: Retrospective Analysis of Outcome After Implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Portal
Liver Cirrhosis
Variceal Hemorrhage
Ascites Hepatic
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: transplantation free survival
timeFrame: from date of TIPS until the event, up to 4 years
Secondary outcomes:
measure: occurrence of hepatic encephalopathy
timeFrame: from date of TIPS until the event, up to 4 years
measure: occurrence of ascites
timeFrame: from date of TIPS until the event, up to 4 years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
References:
citation: Furschuss L, Rainer F, Effenberger M, Niederreiter M, Portugaller RH, Horvath A, Fickert P, Stadlbauer V. A novel score predicts mortality after transjugular intrahepatic portosystemic shunt: MOTS - Modified TIPS Score. Liver Int. 2022 Aug;42(8):1849-1860. doi: 10.1111/liv.15236. Epub 2022 Apr 1.