Non-invasive Evaluation Program for TIPS and Follow Up Network 2 (NEPTUN2)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Non-invasive Evaluation of Prognostic Parameters for Patients With Transjugular Intrahepatic Portosystemic Shunt (TIPS) Using a Structured Follow up Protocol 2

Conditions
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Portal Hypertension

Intervention / Treatment
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* Device: TIPS procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Insertion of TIPS according to guidelines Exclusion Criteria: Contraindication for TIPS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective<br>Prospective cohort that received TIPS from 05/12/2020 onwards | Device: TIPS procedure<br>* Implantation of TIPS for portal hypertension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | death, liver transplantation | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ascites | Evaluation of amount of ascites according to the Child-Score (0=none;1=moderate/treatable; 2=severe/refractory) | up to 10 years | 
| Hepatic Encephalopathy (HE) | Evaluation of the grade according to the West Haven Criteria (Grade 0 (no HE) - Grade 4 (hepatic coma)) | up to 10 years | 
| Variceal Bleeding | Assessment of presence of variceal bleeding | up to 10 years | 
| Liver Failure | defined as Bilirubin level ≥ 12mg/dl | up to 10 years | 
| Acute-on-Chronic Liver Failure (ACLF) | Presence of ACLF according to the EASL-Chronic liver Failure Consortium (CLIF)-criteria | up to 10 years | 
| Organ Failures | Assessment of Organ failures according to CLIF-Sequential Organ Failure Assessment (SOFA) Score (Score 6 (best) to 18 (worst)) | up to 10 years | 
| Kidney Failure | Assessment of AKI according to KDIGO definition | up to 10 years | 
| Sarcopenia | Assessment of sarcopenia according to EASL-guideline definition | up to 10 years | 
| post-surgical survival | Assessment of post-surgical survival | up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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