Austrian Registry on Transjugular Intrahepatic Portosystemic Shunts

Portal Hypertension Clinical Trial

— AUTIPS  

Official title:

Österreichisches Register (Inklusive Biobank) für transjuguläre Intrahepatische Portosystemischem Shunts (TIPS): AUTIPS (AUstrian TIPS Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03409263
• Other study ID #: AUTIPS 1943/2017
• Status: Recruiting
• Start date: March 28, 2018
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: Medical University of Vienna
• Contact: Thomas Reiberger, MD
• Phone: +43140400
• Email: thomas.reiberger[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension, Portal
• Portal Hypertension

Intervention

Other:
• Observational study
Not applicable (observational registry study)

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Reiberger	Austrian Association of Gastroenterology and Hepatology

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transplant-free survival	Assessment of transplant-free survival after TIPS implantation	0-10 years
Secondary	Assessment of portalhypertensive complications	Incidence of portalhypertensive complications	0-10 years
Secondary	Assessment of hepatic encephalopathy	Incidence of hepatic encephalopathy	0-10 years
Secondary	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
Secondary	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