Non-invasive Evaluation Program for TIPS and Follow Up Network

NCT ID: NCT03628807

Last Updated: 2020-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

747 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-01-01

Study Completion Date

2020-05-11

Brief Summary

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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

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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.

Conditions

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Portal Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Retrospective 1

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

No interventions assigned to this group

Retrospective 2

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

No interventions assigned to this group

Prospective

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Insertion of TIPS according to guidelines

Exclusion Criteria

* Contraindication for TIPS
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Jonel Trebicka

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Praktiknjo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bonn

Locations

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University Hospital Bonn

Bonn, , Germany

Site Status

Countries

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Germany

References

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Meyer C, Kimmann M, Bohm K, Nowak S, Perez AMP, Meier JA, Reinartz Groba SN, Godiker J, Uschner FE, Sanoubara F, Chang J, Trebicka J, Sprinkart AM, Praktiknjo M. Three-Dimensional Transjugular Intrahepatic Portosystemic Shunt Geometry Predicts Shunt Dysfunction. Aliment Pharmacol Ther. 2025 Jun;61(11):1805-1814. doi: 10.1111/apt.70133. Epub 2025 Apr 9.

Reference Type DERIVED
PMID: 40202365 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35869810 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34013182 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31448496 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30739387 (View on PubMed)

Other Identifiers

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NEPTUN

Identifier Type: -

Identifier Source: org_study_id

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