Non-invasive Evaluation Program for TIPS and Follow Up Network 2 (NEPTUN2)
ConditionPortal Hypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity Hospital, Bonn
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Insertion of TIPS according to guidelines
Disqualifiers
Contraindication for TIPS
Trial population
All patients receiving TIPS according to guidelines
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
TIPS procedure
DeviceImplantation of TIPS for portal hypertension
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Prospective1 intervention
Trial outcomes
Primary outcomes
1
Survival
death, liver transplantation
Time frame
up to 10 yearsSecondary outcomes
1
Ascites
Evaluation of amount of ascites according to the Child-Score (0=none;1=moderate/treatable; 2=severe/refractory)
Time frame
up to 10 years2
Hepatic Encephalopathy (HE)
Evaluation of the grade according to the West Haven Criteria (Grade 0 (no HE) - Grade 4 (hepatic coma))
Time frame
up to 10 years3
Variceal Bleeding
Assessment of presence of variceal bleeding
Time frame
up to 10 years4
Liver Failure
defined as Bilirubin level ≥ 12mg/dl
Time frame
up to 10 yearsSponsors and contacts
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Source ClinicalTrials.gov