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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04393519
Other study ID # NEPTUN2
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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