Medical University of Vienna
Vienna, State of Vienna, 1090, Austria
Location status: Recruiting
Recruiting
NCT Number: NCT03409263
Austrian Registry on Transjugular Intrahepatic Portosystemic Shunts
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–99 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
observational study
OtherNot applicable (observational registry study)
Primary outcomes
-
Transplant-free survival
Time frame: 0-10 years
Assessment of transplant-free survival after TIPS implantation
Secondary outcomes
-
Assessment of portalhypertensive complications
Time frame: 0-10 years
Incidence of portalhypertensive complications
-
Assessment of hepatic encephalopathy
Time frame: 0-10 years
Incidence of hepatic encephalopathy
-
Assessment of Patient Reported Quality of Life (SF36v2)
Time frame: 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 Patient Reported Quality of Life (CLDQ)
Time frame: 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").
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Thomas Reiberger
Other
Collaborators
- Austrian Association of Gastroenterology and Hepatology
Registry information
Official study title
Österreichisches Register (inklusive Biobank) Für Transjuguläre Intrahepatische Portosystemischem Shunts (TIPS): AUTIPS (AUstrian TIPS Study)
Acronym: AUTIPS
Important dates
- Study start
- 2018
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jan 24, 2018
- Registry last updated
- Nov 6, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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