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

Portal Hypertension Clinical Trial

— NEPTUN2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04393519
• Other study ID #: NEPTUN2
• Status: Recruiting
• Start date: May 12, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: October 2021
• Source: University Hospital, Bonn
• Contact: Michael Praktiknjo, MD
• Phone: +49(0)228-287 15770
• Email: michael.praktiknjo[@]ukbonn.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Insertion of TIPS according to guidelines

Exclusion Criteria:

• Contraindication for TIPS

Related Conditions & MeSH terms

• Hypertension, Portal
• Portal Hypertension

Intervention

Device:
• TIPS procedure
Implantation of TIPS for portal hypertension

Locations

Country	Name	City	State
Germany	University Hospital Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	death, liver transplantation	up to 10 years
Secondary	Ascites	Evaluation of amount of ascites according to the Child-Score (0=none;1=moderate/treatable; 2=severe/refractory)	up to 10 years
Secondary	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
Secondary	Variceal Bleeding	Assessment of presence of variceal bleeding	up to 10 years
Secondary	Liver Failure	defined as Bilirubin level = 12mg/dl	up to 10 years
Secondary	Acute-on-Chronic Liver Failure (ACLF)	Presence of ACLF according to the EASL-Chronic liver Failure Consortium (CLIF)-criteria	up to 10 years
Secondary	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
Secondary	Kidney Failure	Assessment of AKI according to KDIGO definition	up to 10 years
Secondary	Sarcopenia	Assessment of sarcopenia according to EASL-guideline definition	up to 10 years
Secondary	post-surgical survival	Assessment of post-surgical survival	up to 10 years