Austrian Registry on Transjugular Intrahepatic Portosystemic Shunts (AUTIPS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Portal Hypertension
• Intervention / Treatment: Other: Observational study

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 Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Thomas Reiberger, MD; Phone Number: 47440 +43140400; Email: thomas.reiberger@meduniwien.ac.at
• Study Contact Backup: Name: Lukas Hartl, MD; Phone Number: 65890 +43140400; Email: lukas.a.hartl@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Thomas Reiberger, M.D.; Phone Number: 47440 +43140400; Email: thomas.reiberger@meduniwien.ac.at
    • Contact: Lukas Hartl, M.D.; Phone Number: 65890 +43140400; Email: lukas.a.hartl@meduniwien.ac.at
    • Contact: Mattias Mandorfer, M.D., Ph.D.
    • Contact: Bernhard Scheiner, M.D.
    • Contact: Thomas Reiberger, M.D.
    • Contact: Theresa Bucsics, M.D.
    • Contact: Lukas Hartl, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Inpatients or outpatients who are scheduled for TIPS implantation, or who have recently undergone TIPS implantation and are visiting outpatienc clinics for control visits/surveillance

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transplant-free survival	Assessment of transplant-free survival after TIPS implantation	0-10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of portalhypertensive complications	Incidence of portalhypertensive complications	0-10 years
Assessment of hepatic encephalopathy	Incidence of hepatic encephalopathy	0-10 years
Assessment of Patient Reported Quality of Life (SF36v2)	Validated Questionnaire: SF36v2 pre TIPS and after TIPS. The SF36 consists of 36 items measuring 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The mental (MCS) and physical (PCS) component summary scores, as the main read-outs of the SF-36 form, can be regarded as physiological ('normal') when the calculated score lies between 45 and 55, because the results are normalized to a normal "reference" population assigned 50 points. Scores below 45 define worse-than-average physical (PCS) or mental (MCS) health, while scores above 55 indicate better-than-average physical (PCS) or mental (MCS) health, when compared to a normal population.	0-10 years
Assessment of Patient Reported Quality of Life (CLDQ)	Validated Questionnaire CLDQ pre TIPS and after TIPS The CLDQ includes 29 items in the following domains: abdominal symptoms, fatigue, systemic symptoms, activity, emotional function and worry. The responses in the 29 CLDQ items, respectively, are recorded on scales ranging from in 1 ("none of the time") to 7 ("all of the time").	0-10 years

Collaborators and Investigators

• Sponsor: Thomas Reiberger
• Collaborators: Austrian Association of Gastroenterology and Hepatology
• Investigators: Principal Investigator: Thomas Reiberger, MD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Cirrhosis; Ascites; Advanced chronic liver disease; Variceal hemorrhage; Transjugular intrahepatic portosystemic shunt
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hypertension, Portal
• Other Study ID Numbers: AUTIPS 1943/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data may not be shared publicly due to local data safety regulations. Please contact the sponsor for more information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No