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Recruiting NCT04393519

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

Observational Portal Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TIPS procedure.
Who it may be relevant to
Registry conditions: Portal Hypertension. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

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

  • Device TIPS procedure
    Implantation of TIPS for portal hypertension

Primary outcome measures

  • Survival [Time frame: up to 10 years]
Secondary outcome measures (9)
  • Ascites [Time frame: up to 10 years]
  • Hepatic Encephalopathy (HE) [Time frame: up to 10 years]
  • Variceal Bleeding [Time frame: up to 10 years]
  • Liver Failure [Time frame: up to 10 years]
  • Acute-on-Chronic Liver Failure (ACLF) [Time frame: up to 10 years]
  • Organ Failures [Time frame: up to 10 years]
  • Kidney Failure [Time frame: up to 10 years]
  • Sarcopenia [Time frame: up to 10 years]
  • post-surgical survival [Time frame: up to 10 years]

Eligibility criteria

Inclusion criteria

  • Insertion of TIPS according to guidelines

Exclusion criteria

  • Contraindication for TIPS

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • University Hospital Bonn — Bonn

Publications

  • Heger LA, Chang J, Rohrer C, Reincke M, Eyth A, Sturm L, Schultheiss M, Maier A, Meyer C, Jansen C, Graf K, Ozturk C, Schneider F, Trebicka J, Westermann D, Thimme R, Grundmann S, Praktiknjo M, Bettinger D. Right Ventricular Contractility Predicts Clearance of Ascites After Transjugular Intrahepatic Portosystemic Shunt. Liver Int. 2025 Dec;45(12):e70422. doi: 10.1111/liv.70422. PMID 41204773

Identifiers

NCT: NCT04393519 · NEPTUN2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗