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

University Hospital, Bonn1,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Portal Hypertension

Interventions

TIPS procedureDEVICE

Implantation of TIPS for portal hypertension

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Bonn

Bonn, Germany

RECRUITING

Outcomes

Primary Outcomes

Survival

death, liver transplantation

Time frame: up to 10 years

Secondary Outcomes

Ascites

Evaluation of amount of ascites according to the Child-Score (0=none;1=moderate/treatable; 2=severe/refractory)

Time frame: 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))

Time frame: up to 10 years

Variceal Bleeding

Assessment of presence of variceal bleeding

Time frame: up to 10 years

Liver Failure

defined as Bilirubin level ≥ 12mg/dl

Time frame: up to 10 years

Acute-on-Chronic Liver Failure (ACLF)

Presence of ACLF according to the EASL-Chronic liver Failure Consortium (CLIF)-criteria

Time frame: 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))

Time frame: up to 10 years

Kidney Failure

Assessment of AKI according to KDIGO definition

Time frame: up to 10 years

Sarcopenia

Central Contacts

Michael Praktiknjo, MD

CONTACT

+49(0)228-287 15770 michael.praktiknjo@ukbonn.de

Johannes Chang, MD

CONTACT

+49(0)228-287 15770 johannes.chang@ukbonn.de

Data from ClinicalTrials.gov

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