Non-invasive Evaluation Program for TIPS and Follow Up Network

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

Conditions
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Portal Hypertension

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 |
| --- | --- |
| Retrospective 1<br>Retrospective Bare Metal Stent Cohort that received TIPS from 01/01/1996 to 12/31/2003. | |
| Retrospective 2<br>Retrospective Covered Stent Cohort that received TIPS from 01/01/2004 to 12/31/2012. | |
| Prospective<br>Prospective cohort that received TIPS from 01/01/2013 onwards | |

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 | up to 10 years | 
| Hepatic Encephalopathy | Evaluation of the grade according to the West Haven Criteria | 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 the CLIF-SOFA according to CLIF-Sequential Organ Failure Assessment (SOFA) Score | up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transthoracic echocardiography (TTE) with Speckle-tracking, Computer tomography scan (CT-scan), Magnetic resonance imaging (MRI), Electroencephalography (EEG), transjugular intrahepatic portosystemic shunt (TIPS), non-invasive assessments, circulating biomarkers