Austrian Registry on Transjugular Intrahepatic Portosystemic Shunts
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational study.
- Who it may be relevant to
- Registry conditions: Portal Hypertension. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Österreichisches Register (inklusive Biobank) Für Transjuguläre Intrahepatische Portosystemischem Shunts (TIPS): AUTIPS (AUstrian TIPS Study)
Overview
Patients with TIPS will be recruited in this prospective registry study. The clinical course will be documented and biomarkers for prediction of complicatiosn will be assessed.
Detailed description
Patients with advanced chronic liver disease may develop portal hypertension, which is the main cause for most complications and deaths of patients with liver cirrhosis. Implantation of a transjugular intrahepatic portosystemic shunt (TIPS) leads to instantaneous alleviation of portal hypertension, but may cause hepatic encephalopathy. Stent grafts, as well as patient stratification and medical surveillance, have drastically improved over the past decades. However, there are few data on long-term outcome after TIPS implantation.This prospective registry study will assess the clinical course of patients after undergoing TIPS intervention and biomarkers for complications after TIPS implantation.
Interventions
- Other Observational study
Not applicable (observational registry study)
Primary outcome measures
- Transplant-free survival [Time frame: 0-10 years]
Secondary outcome measures (4)
- Assessment of portalhypertensive complications [Time frame: 0-10 years]
- Assessment of hepatic encephalopathy [Time frame: 0-10 years]
- Assessment of Patient Reported Quality of Life (SF36v2) [Time frame: 0-10 years]
- Assessment of Patient Reported Quality of Life (CLDQ) [Time frame: 0-10 years]
Eligibility criteria
Inclusion criteria
- Age 18-99 years
- Portal hypertension
- Anticipated or past implantation of a transjugular intrahepatic portosystemic shunt (TIPS)
- Informed consent
Exclusion criteria
- Retraction of consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Austria · 1 center
- Medical University of Vienna — Vienna
Identifiers
NCT: NCT03409263 · AUTIPS 1943/2017