Deprescribing Proton Pump Inhibitors to Reduce Post-TIPS Hepatic Encephalopathy

  • STATUS
    Recruiting
  • End date
    Oct 22, 2023
  • participants needed
    40
  • sponsor
    Duke University
Updated on 22 March 2022
encephalopathy
psychometric testing
portosystemic shunt

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.

Details
Condition Hepatic Encephalopathy
Treatment PPI deprescribing
Clinical Study IdentifierNCT05070351
SponsorDuke University
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Undergoing TIPS creation as part of routine clinical care
On PPIs therapy (at least 20 mg omeprazole equivalent daily)
Provision of signed and dated informed consent form by participant or legal representative
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, age greater or equal to 18

Exclusion Criteria

Grade IV esophagitis or gastric or duodenal ulcer
Recent endoscopic esophageal variceal band ligation necessitating PPI therapy for prevention of banding ulcer
Zollinger-Ellison syndrome
Active Helicobacter pylori infection
Pregnancy
Clear my responses

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