NCT03628807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
747

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
19.5 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2020

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

21.4 years

First QC Date

July 11, 2018

Last Update Submit

May 11, 2020

Conditions

Portal Hypertension

Keywords

transjugular intrahepatic portosystemic shunt (TIPS)non-invasive assessmentsTransthoracic echocardiography (TTE) with Speckle-trackingComputer tomography scan (CT-scan)Magnetic resonance imaging (MRI)circulating biomarkersElectroencephalography (EEG)

Outcome Measures

Primary Outcomes (1)

  • Survival

    death, liver transplantation

    up to 10 years

Secondary Outcomes (6)

  • Ascites

    up to 10 years

  • Hepatic Encephalopathy

    up to 10 years

  • Variceal Bleeding

    up to 10 years

  • Liver Failure

    up to 10 years

  • Acute-on-Chronic-Liver Failure (ACLF)

    up to 10 years

  • +1 more secondary outcomes

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients receiving TIPS according to guidelines

You may qualify if:

  • Insertion of TIPS according to guidelines

You may not qualify if:

  • Contraindication for TIPS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bonn

Bonn, Germany

Location

Related Publications (5)

  • 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.

    PMID: 40202365DERIVED

  • 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.

    PMID: 35869810DERIVED

  • 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.

    PMID: 34013182DERIVED

  • 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.

    PMID: 31448496DERIVED

  • 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.

    PMID: 30739387DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, stool, DNA, PBMC, Buffi coat

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Michael Praktiknjo, MD

    University of Bonn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 11, 2018

First Posted

August 14, 2018

Study Start

January 1, 1999

Primary Completion

May 11, 2020

Study Completion

May 11, 2020

Last Updated

May 12, 2020

Record last verified: 2020-05

Locations

DE(1)