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), Elastography
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
DEVICETIPS procedure
Implantation of TIPS for portal hypertension
Sponsors
University Hospital, Bonn
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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 |
|---|---|---|
| Hepatic Encephalopathy (HE) | up to 10 years | Evaluation of the grade according to the West Haven Criteria (Grade 0 (no HE) - Grade 4 (hepatic coma)) |
| Variceal Bleeding | up to 10 years | Assessment of presence of variceal bleeding |
| 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 |
| Ascites | up to 10 years | Evaluation of amount of ascites according to the Child-Score (0=none;1=moderate/treatable; 2=severe/refractory) |
| Kidney Failure | up to 10 years | Assessment of AKI according to KDIGO definition |
| Sarcopenia | up to 10 years | Assessment of sarcopenia according to EASL-guideline definition |
| post-surgical survival | up to 10 years | Assessment of post-surgical survival |
| Organ Failures | up to 10 years | Assessment of Organ failures according to CLIF-Sequential Organ Failure Assessment (SOFA) Score (Score 6 (best) to 18 (worst)) |
Countries
Germany
Contacts
Primary ContactMichael Praktiknjo, MD
Backup ContactJohannes Chang, MD
Outcome results
None listed