Clinical trial NCT03628807: Non-invasive Evaluation Program for TIPS and Follow Up Network
Official title: Non-invasive Evaluation of Prognostic Parameters for Patients With Transjugular Intrahepatic Portosystemic Shunt (TIPS) Using a Structured Follow up Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Portal Hypertension
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)
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 747
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients receiving TIPS according to guidelines

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.

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.

Eligibility criteria: Inclusion Criteria:

* Insertion of TIPS according to guidelines

Exclusion Criteria:

* Contraindication for TIPS

Primary outcomes:
measure: Survival
timeFrame: up to 10 years
Secondary outcomes:
measure: Ascites
timeFrame: up to 10 years
measure: Hepatic Encephalopathy
timeFrame: up to 10 years
measure: Variceal Bleeding
timeFrame: up to 10 years
measure: Liver Failure
timeFrame: up to 10 years
measure: Acute-on-Chronic-Liver Failure (ACLF)
timeFrame: up to 10 years
measure: Organ Failures
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn
Study officials:
affiliation: University of Bonn
name: Michael Praktiknjo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.