Portal Hypertension
Conditions
Keywords
transjugular intrahepatic portosystemic shunt (TIPS), non-invasive assessments, Transthoracic echocardiography (TTE) with Speckle-tracking, Computer tomography scan (CT-scan), Magnetic resonance imaging (MRI), circulating biomarkers, Electroencephalography (EEG)
Brief summary
Evaluation of non-invasive prognostic parameters in patients receiving transjugular intrahepatic portosystemic shunt (TIPS) for complications of portal hypertension. Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.
Detailed description
NEPTUN consists of liver cirrhosis receiving transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Internal Medicine I, University of Bonn, Germany and receiving a structured routine evaluation and follow up program. The diagnosis of cirrhosis was based on clinical, hemodynamic and biochemical parameters, and ultrasound and/or biopsy criteria.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Insertion of TIPS according to guidelines
Exclusion criteria
* Contraindication for TIPS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | up to 10 years | death, liver transplantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ascites | up to 10 years | Evaluation of amount of ascites according to the Child-Score |
| Hepatic Encephalopathy | up to 10 years | Evaluation of the grade according to the West Haven Criteria |
| Organ Failures | up to 10 years | Assessment of Organ failures according to the CLIF-SOFA according to CLIF-Sequential Organ Failure Assessment (SOFA) Score |
| Liver Failure | up to 10 years | defined as Bilirubin level ≥ 12mg/dl |
| Acute-on-Chronic-Liver Failure (ACLF) | up to 10 years | Presence of ACLF according to the EASL-Chronic liver Failure Consortium (CLIF)-criteria |
| Variceal Bleeding | up to 10 years | Assessment of presence of variceal bleeding |
Countries
Germany