Österreichisches Register (inklusive Biobank) Für Transjuguläre Intrahepatische Portosystemischem Shunts (TIPS): AUTIPS (AUstrian TIPS Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Transplant-free survival
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Transplant-free survival
Time Frame: 0-10 years
Assessment of transplant-free survival after TIPS implantation
Secondary Outcomes
- Assessment of portalhypertensive complications(0-10 years)
- Assessment of Patient Reported Quality of Life (SF36v2)(0-10 years)
- Assessment of hepatic encephalopathy(0-10 years)
- Assessment of Patient Reported Quality of Life (CLDQ)(0-10 years)
Investigators
Thomas Reiberger
Univ. Prof. Priv.-Doz. Dr.
Medical University of Vienna