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

Recruiting

• Conditions: Portal Hypertension
• Interventions: Device: TIPS procedure

• Registration Number: NCT04393519
• Lead Sponsor: University Hospital, Bonn

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.

Study Timeline

• Study Start: 2020-05-12
• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-16
• Study First Posted: 2020-05-19
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-05
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Insertion of TIPS according to guidelines

Exclusion Criteria

• Contraindication for TIPS

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective	TIPS procedure	Prospective cohort that received TIPS from 05/12/2020 onwards

Primary Outcome Measures

Name	Time	Method
Survival	up to 10 years	death, liver transplantation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Bonn; 🇩🇪 Bonn, Germany