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INTRODUCTION

Patients undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement have an increased risk of development of overt hepatic encephalopathy (OHE). Approximately 33% of the patients develop post-TIPS placement OHE. A drug treatment is available: rifaximin in combination with lactulose. However, no prophylactic strategy is currently in use to prevent OHE.

 

RESEARCH QUESTION

Can the incidence of overt hepatic encephalopathy after transjugular intrahepatic portosystemic shunt placement be decreased by prophylactic administration of rifaximin and lactulose?

 

HYPOTHESIS

Prophylactic administration of rifaximin and lactulose will lead to a decreased incidence of post-TIPS overt hepatic encephalopathy.

 

STUDY DESIGN

A multicentre, double blind, randomized, placebo-controlled trial.

 

STUDY POPULATION

Adult patients with proven liver cirrhosis undergoing elective TIPS placement in all Dutch academic centres who perform TIPS procedures: AMC, Erasmus MC, LUMC, MUMC+, RadboudUMC, UMCG, and UZ Leuven in Belgium.

 

INTERVENTION

Administration of rifaximin 550mg b.i.d. and lactulose 25ml b.i.d. (further dependent on the amount of daily bowel movements), from 72 hours before, until three months after TIPS placement. This intervention will be compared to administration of placebo tablets b.i.d. and lactulose 25ml b.i.d., for the same period of time.

 

OUTCOME MEASURES

West Haven Criteria, PHES score, and Critical Flicker Frequency test score, hospital visits/admissions, quality of life (Liver Disease Symptom Index 2.0 (LSDI 2.0) and EQ-5D-5L), 90 day mortality.

 

SAMPLE SIZE/DATA-ANALYSIS

Assuming that the effect of rifaximin and lactulose is a 50% reduction of post-TIPS HE, incidence is expected to drop from 33% to 16,5%. With a 2-sided 5% alpha, power of 80%, and an estimated dropout of 10%, a total of 119 patients are needed in the intervention group, and 119 patients in the control group.

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