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Clinical Trials/NCT03409263
NCT03409263
Recruiting
Not Applicable

Österreichisches Register (inklusive Biobank) Für Transjuguläre Intrahepatische Portosystemischem Shunts (TIPS): AUTIPS (AUstrian TIPS Study)

Thomas Reiberger1 site in 1 country400 target enrollmentMarch 28, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Portal Hypertension
Sponsor
Thomas Reiberger
Enrollment
400
Locations
1
Primary Endpoint
Transplant-free survival
Status
Recruiting
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
March 28, 2018
End Date
December 31, 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Thomas Reiberger
Responsible Party
Sponsor Investigator
Principal Investigator

Thomas Reiberger

Univ. Prof. Priv.-Doz. Dr.

Medical University of Vienna

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

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)

Study Sites (1)

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