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Non-invasive Evaluation Program for TIPS and Follow Up Network

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03628807
Acronym
NEPTUN
Enrollment
747
Registered
2018-08-14
Start date
1999-01-01
Completion date
2020-05-11
Last updated
2020-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Portal Hypertension

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

University Hospital, Bonn
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

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

MeasureTime frameDescription
Survivalup to 10 yearsdeath, liver transplantation

Secondary

MeasureTime frameDescription
Ascitesup to 10 yearsEvaluation of amount of ascites according to the Child-Score
Hepatic Encephalopathyup to 10 yearsEvaluation of the grade according to the West Haven Criteria
Organ Failuresup to 10 yearsAssessment of Organ failures according to the CLIF-SOFA according to CLIF-Sequential Organ Failure Assessment (SOFA) Score
Liver Failureup to 10 yearsdefined as Bilirubin level ≥ 12mg/dl
Acute-on-Chronic-Liver Failure (ACLF)up to 10 yearsPresence of ACLF according to the EASL-Chronic liver Failure Consortium (CLIF)-criteria
Variceal Bleedingup to 10 yearsAssessment of presence of variceal bleeding

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026