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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Elective TIPS placement for refractory ascites or recurrent variceal bleeding:
✓. 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
Exclusion criteria
✕. 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
✕. Non-cirrhotic portal hypertension
✕. Portal vein thrombosis (main trunk)
✕. HIV
What they're measuring
1
post-TIPS Hepatic Encephalopathy
Timeframe: First 3 months after TIPS placement
Trial details
NCT IDNCT04073290
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)