Deprescribing Proton Pump Inhibitors to Reduce Post-TIPS Hepatic Encephalopathy
Status:
Not yet recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
Summary
A total of 40 patients taking proton pump inhibitors (PPIs) who undergo transjugular
intrahepatic portosystemic shunt (TIPS) creation as part of routine clinical care will be
randomized in 1:1 fashion to either continue or discontinue their PPIs to determine whether
these commonly used gastric acid suppressing agents increase risk of post-TIPS hepatic
encephalopathy (HE). Patients will be assessed for symptoms of minimal HE (MHE), using the
established psychometric hepatic encephalopathy score (PHES) battery of tests. MHE assessment
will be conducted at two timepoints: at baseline prior to randomization and TIPS creation and
approximately 4 weeks after randomization and TIPS creation. Stool samples will also be
collected at both timepoints to allow characterization of the gastrointestinal (GI) tract
microbiome using 16S rRNA sequencing. The pre to post-TIPS change in PHES scores will be
compared between patients randomized to continue versus discontinue their PPIs. Quality of
life (QOL) will also be assessed. Changes in the GI tract microbiome will be analyzed to
determine whether this represents a potential biological mechanism linking PPI use with
post-TIPS HE.