Liver Cirrhoses, Portal Hypertension
Conditions
Brief summary
To evaluate the clinical benefits in the patients receiving Viatorr CX over a period of 12 months of structured Follow-up (before TIPS, at TIPS, 1 week after TIPS, at 6 weeks, 4 months, 6 months, 9 months, 12 months), regarding clinical endpoints, such as HE, readmission, liver injury, cardiac function, response to TIPS and the passive expansion of the stents in real life.
Detailed description
Case-control study using the patients in the University Clinic Bonn receiving Viatorr CX (n=40), using a comparison ration 1:1:1 to Viatorr and bare metal stents. Of these patients, 20 patients will receive Viatorr CX and the assessement of the width of the stent as outlined in the JVIR-paper published this year. The Viatorr and BMS controls with similar age, gender, Child, MELD and indication for TIPS. A total of 125 patients with the primary composite-endpoint HE/readmission will be investigated Secondary endpoints are liver injury, cardiac function, response to TIPS and the passive expansion of the stents in real life.
Interventions
DEVICETIPS
Transjugular Intrahepatic Portosystemic Shunt
Sponsors
University Hospital, Bonn
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients suitable for TIPS
Exclusion criteria
* Contraindication for TIPS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Readmissions | 12 months | Number of readmissions will be documented using a structured CRF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hepatic encephalopathy (HE) | 12 months | Number of Episodes of overt HE (West Haven Criteria \> Grad I) |
| Liver injury | 12 months | Increase in liver function tests |
| Response to TIPS | 12 months | grade of ascites after TIPS |
Countries
Germany
Outcome results
None listed