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CompletedNCT03628807NEPTUNUpdated May 12, 2020

Non-invasive Evaluation Program for TIPS and Follow Up Network

An observational study in Portal Hypertension, sponsored by University Hospital, Bonn. Completed at 1 site in Germany. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-05-12.

Sponsored by University Hospital, Bonn · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
747
Ages
18 Years to 100 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Portal Hypertension

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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)
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In context

Hypertension, Portal

332 studies on the registry are indexed under Hypertension, Portal; 106 are open to participants now.

This study's enrollment of 747 is above the median of 152 across 119 observational studies indexed under Hypertension, Portal.

Browse Hypertension, Portal studies →

Lead sponsor

University Hospital, Bonn is the lead sponsor of 154 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients receiving TIPS according to guidelines

Inclusion criteria

  • Insertion of TIPS according to guidelines

Exclusion criteria

Exclusion Criteria:

  • Contraindication for TIPS
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
747 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Retrospective 1

    Retrospective Bare Metal Stent Cohort that received TIPS from 01/01/1996 to 12/31/2003.

  • Retrospective 2

    Retrospective Covered Stent Cohort that received TIPS from 01/01/2004 to 12/31/2012.

  • Prospective

    Prospective cohort that received TIPS from 01/01/2013 onwards

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What researchers measure

Primary outcomes

  1. Survival

    death, liver transplantation

    Time frame: up to 10 years

Secondary outcomes

  1. Ascites

    Evaluation of amount of ascites according to the Child-Score

    Time frame: up to 10 years

  2. Hepatic Encephalopathy

    Evaluation of the grade according to the West Haven Criteria

    Time frame: up to 10 years

  3. Variceal Bleeding

    Assessment of presence of variceal bleeding

    Time frame: up to 10 years

  4. Liver Failure

    defined as Bilirubin level ≥ 12mg/dl

    Time frame: up to 10 years

  5. 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

  6. Organ Failures

    Assessment of Organ failures according to the CLIF-SOFA according to CLIF-Sequential Organ Failure Assessment (SOFA) Score

    Time frame: up to 10 years

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Study locations

1 site
  • University Hospital Bonn
    Bonn, Germany
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References and documents

Publications

  • Queck A, Schwierz L, Gu W, Ferstl PG, Jansen C, Uschner FE, Praktiknjo M, Chang J, Brol MJ, Schepis F, Merli M, Strassburg CP, Lehmann J, Meyer C, Trebicka J. Targeted decrease of portal hepatic pressure gradient improves ascites control after TIPS. Hepatology. 2023 Feb 1;77(2):466-475. doi: 10.1002/hep.32676. Epub 2022 Aug 12. PubMed 35869810 ↗
  • Praktiknjo M, Abu-Omar J, Chang J, Thomas D, Jansen C, Kupczyk P, Schepis F, Garcia-Pagan JC, Merli M, Meyer C, Strassburg CP, Pieper CC, Trebicka J. Controlled underdilation using novel VIATORR(R) controlled expansion stents improves survival after transjugular intrahepatic portosystemic shunt implantation. JHEP Rep. 2021 Mar 3;3(3):100264. doi: 10.1016/j.jhepr.2021.100264. eCollection 2021 Jun. PubMed 34013182 ↗
  • Torner M, Mangal A, Scharnagl H, Jansen C, Praktiknjo M, Queck A, Gu W, Schierwagen R, Lehmann J, Uschner FE, Graf C, Strassburg CP, Fernandez J, Stojakovic T, Woitas R, Trebicka J. Sex specificity of kidney markers to assess prognosis in cirrhotic patients with TIPS. Liver Int. 2020 Jan;40(1):186-193. doi: 10.1111/liv.14230. Epub 2019 Sep 10. PubMed 31448496 ↗
  • Lehmann J, Praktiknjo M, Nielsen MJ, Schierwagen R, Meyer C, Thomas D, Violi F, Strassburg CP, Bendtsen F, Moller S, Krag A, Karsdal MA, Leeming DJ, Trebicka J. Collagen type IV remodelling gender-specifically predicts mortality in decompensated cirrhosis. Liver Int. 2019 May;39(5):885-893. doi: 10.1111/liv.14070. Epub 2019 Mar 7. PubMed 30739387 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03628807
Lead sponsor
University Hospital, Bonn
Responsible party
Jonel Trebicka (Professor, University Hospital, Bonn) — Principal investigator
First posted
Aug 14, 2018
Start date
Jan 1, 1999
Primary completion
May 11, 2020
Completion
May 11, 2020
Last update
May 12, 2020

Study contacts

Michael Praktiknjo, MD
principal investigator · University of Bonn

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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