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NCT Number: NCT04393519

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

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.

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Key information

Conditions

Portal Hypertension Digestive System Diseases Hypertension, Portal Liver Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Insertion of TIPS according to guidelines

Exclusion criteria

  • Contraindication for TIPS

Treatment and study plan

TIPS procedure

Device

Implantation of TIPS for portal hypertension

Primary outcomes

  1. Survival

    Time frame: up to 10 years

    death, liver transplantation

Secondary outcomes

  1. Ascites

    Time frame: up to 10 years

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

  2. Hepatic Encephalopathy (HE)

    Time frame: up to 10 years

    Evaluation of the grade according to the West Haven Criteria (Grade 0 (no HE) - Grade 4 (hepatic coma))

  3. Variceal Bleeding

    Time frame: up to 10 years

    Assessment of presence of variceal bleeding

  4. Liver Failure

    Time frame: up to 10 years

    defined as Bilirubin level ≥ 12mg/dl

  5. Acute-on-Chronic Liver Failure (ACLF)

    Time frame: up to 10 years

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

  6. Organ Failures

    Time frame: up to 10 years

    Assessment of Organ failures according to CLIF-Sequential Organ Failure Assessment (SOFA) Score (Score 6 (best) to 18 (worst))

  7. Kidney Failure

    Time frame: up to 10 years

    Assessment of AKI according to KDIGO definition

  8. Sarcopenia

    Time frame: up to 10 years

    Assessment of sarcopenia according to EASL-guideline definition

  9. post-surgical survival

    Time frame: up to 10 years

    Assessment of post-surgical survival

Study contacts

Contact information is provided by the study sponsor or research team.

Johannes Chang, MD

CONTACT

[email protected]

+49(0)228-287 15770

Michael Praktiknjo, MD

CONTACT

[email protected]

+49(0)228-287 15770

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Official study title

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

Acronym: NEPTUN2

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
May 19, 2020
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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