Austrian Registry on Transjugular Intrahepatic Portosystemic Shunts

Recruiting

• Conditions: Portal Hypertension

• Registration Number: NCT03409263
• Lead Sponsor: Thomas Reiberger

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 Timeline

• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-24
• Study Start: 2018-03-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transplant-free survival	0-10 years	Assessment of transplant-free survival after TIPS implantation

Secondary Outcome Measures

Name	Time	Method
Assessment of portalhypertensive complications	0-10 years	Incidence of portalhypertensive complications
Assessment of Patient Reported Quality of Life (SF36v2)	0-10 years	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.
Assessment of hepatic encephalopathy	0-10 years	Incidence of hepatic encephalopathy
Assessment of Patient Reported Quality of Life (CLDQ)	0-10 years	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").

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria