Portal Hypertension
Conditions
Keywords
Cirrhosis, Advanced chronic liver disease, Ascites, Variceal hemorrhage, Transjugular intrahepatic portosystemic shunt
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.
Interventions
OTHERObservational study
Not applicable (observational registry study)
Sponsors
Austrian Association of Gastroenterology and Hepatology
Thomas Reiberger
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transplant-free survival | 0-10 years | Assessment of transplant-free survival after TIPS implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of portalhypertensive complications | 0-10 years | Incidence of portalhypertensive complications |
| Assessment of hepatic encephalopathy | 0-10 years | Incidence of hepatic encephalopathy |
| 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 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). |
Countries
Austria
Contacts
Primary ContactThomas Reiberger, MD
Backup ContactLukas Hartl, MD
Outcome results
None listed