The PEARL trial: Prevention of hepatic Encephalopathy by administration of Rifaximin and Lactulose in patients with liver cirrhosis undergoing placement of a transjugular intrahepatic portosystemic shunt: a multi-centre randomized, double blind, placebo controlled trial.

Confirmed diagnosis of Alcoholic liver cirrhosis

Primary endpoint is the development of OHE within three months after TIPS placement determined by the West Haven criteria.

Secondary endpoints include 90-day mortality; development of a second episode of OHE within the first three months; development of OHE in the period between three and twelve months after TIPS placement; development of MHE between TIPS placement and twelve months post-placement; time to development of OHE or MHE episodes; the increase in PHES, S-ANT1 score and LFI compared to baseline.

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Belgium, Netherlands