Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose

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.

NCT Number	NCT04073290
Lead Sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Collaborators: Erasmus Medical Center, Leiden University Medical Center, Maastricht University Medical Center, Radboud University Medical Center, University Medical Center Groningen, Universitaire Ziekenhuizen KU Leuven, Norgine
Conditions	Hepatic Encephalopathy, Cirrhosis, Liver, Portal Hypertension, Liver Diseases, Pathological Processes
Enrollment	238 participants
Start Date	2020-01-21
Primary Completion	2026-09-30 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-01-28