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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Portal Hypertension
• Intervention / Treatment: Device: TIPS procedure

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Michael Praktiknjo, MD; Phone Number: +49(0)228-287 15770; Email: michael.praktiknjo@ukbonn.de
• Study Contact Backup: Name: Johannes Chang, MD; Phone Number: +49(0)228-287 15770; Email: johannes.chang@ukbonn.de

Study Locations

• Germany
  • Bonn, Germany
    • Recruiting
    • University Hospital Bonn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients receiving TIPS according to guidelines

Description

Inclusion Criteria:

• Insertion of TIPS according to guidelines

Exclusion Criteria:

• Contraindication for TIPS

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective; Prospective cohort that received TIPS from 05/12/2020 onwards	Device: TIPS procedure; Implantation of TIPS for portal hypertension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	death, liver transplantation	up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ascites	Evaluation of amount of ascites according to the Child-Score (0=none;1=moderate/treatable; 2=severe/refractory)	up to 10 years
Hepatic Encephalopathy (HE)	Evaluation of the grade according to the West Haven Criteria (Grade 0 (no HE) - Grade 4 (hepatic coma))	up to 10 years
Variceal Bleeding	Assessment of presence of variceal bleeding	up to 10 years
Liver Failure	defined as Bilirubin level ≥ 12mg/dl	up to 10 years
Acute-on-Chronic Liver Failure (ACLF)	Presence of ACLF according to the EASL-Chronic liver Failure Consortium (CLIF)-criteria	up to 10 years
Organ Failures	Assessment of Organ failures according to CLIF-Sequential Organ Failure Assessment (SOFA) Score (Score 6 (best) to 18 (worst))	up to 10 years
Kidney Failure	Assessment of AKI according to KDIGO definition	up to 10 years
Sarcopenia	Assessment of sarcopenia according to EASL-guideline definition	up to 10 years
post-surgical survival	Assessment of post-surgical survival	up to 10 years

Collaborators and Investigators

• Sponsor: University Hospital, Bonn
• Investigators: Principal Investigator: Michael Praktiknjo, MD, University of Bonn

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 12, 2020
• Primary Completion (ANTICIPATED): December 31, 2030
• Study Completion (ANTICIPATED): December 31, 2030

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 16, 2020
• First Posted (ACTUAL): May 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Elastography; Magnetic resonance imaging (MRI); Electroencephalography (EEG); transjugular intrahepatic portosystemic shunt (TIPS); Circulating biomarkers; non-invasive assessments; Transthoracic echocardiography (TTE) with Speckle-tracking; Computer tomography scan (CT-scan)
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hypertension, Portal
• Other Study ID Numbers: NEPTUN2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No