Rationale: Hepatic encephalopathy (HE) is a major and common complication in patients with liver cirrhosis. HE can be classified in the extensive range of neurocognitive deterioration as minimal HE (MHE), covert HE (grade I), or overt HE (OHE, grade II-IV). Liver cirrhosis is the most common cause of portal hypertension (PH). Patients who develop complications of PH, like variceal bleeding or refractory ascites, can benefit from a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement. Unfortunately, post-TIPS HE is a common and often severe complication. Incidence of new onset or worsening of HE after TIPS is approximately 20-45%. Currently there is no strategy to prevent post-TIPS HE.
Age ≥18 years
Confirmed liver cirrhosis as documented by liver biopsy, elastography (e.g. Fibroscan) or combination of usual radiological and biochemical criteria.
Signed informed consent
Any absolute contraindications for TIPS placement
Use of ciclosporin
Life-threatening variceal bleeding with emergency TIPS placement which can not be delayed 72 hours
Age > 80 years
Parallel
Rifaximin 550 milligram Oral Tablet [XIFAXAN]
DrugRifaximin 550 milligram b.i.d. 72 hours before TIPS placement till 3 months post-TIPS
Placebo oral tablet
DrugPlacebo b.i.d. 72 hours before TIPS placement till 3 months post-TIPS
Lactulose 667 milligram/milliliter Oral Solution
DrugLactulose based on soft stool frequency, 72 hours before TIPS placement till 3 months post-TIPS
post-TIPS Hepatic Encephalopathy
post-TIPS Hepatic Encephalopathy
Mortality
Mortality
Transplant free survival
Transplant free survival
time to development of post-TIPS HE episode(s)
time to development of post-TIPS HE episode(s)
development of a second episode of post-TIPS HE
development of a second episode of post-TIPS HE
Health related Quality of life
Health related Quality of life, measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire
Disease rrelated Quality of life
Health related Quality of life, Liver Disease Symptom Index (LDSI) 2.0 questionnaire.
Cost-effectiveness
Cost-effectiveness, measured by a combined questionnaire, based on institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ)/Medical Consumption Questionnaire (iMCQ)
Click on the lead sponsor to view all of their trials.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Erasmus Medical Center
Collaborator
Leiden University Medical Center
Collaborator
Maastricht University Medical Center
Collaborator
Radboud University Medical Center
Collaborator
University Medical Center Groningen
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator
Norgine
Collaborator
