Deprescribing Proton Pump Inhibitors to Reduce Post-TIPS Hepatic Encephalopathy

Duke University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hepatic Encephalopathy

Treatments: Drug: PPI deprescribing

Study type: Interventional

Funder types: Other

Identifiers

NCT05070351

Pro00108517

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 2 patient groups

PPI deprescribing arm

Experimental group

Description:

Patients taking a PPI (at least 20 mg omeprazole equivalent daily) will be instructed to stop taking their PPI.

Treatment:

Drug: PPI deprescribing

PPI continuation arm

No Intervention group

Description:

Patients will be instructed to continue taking their PPI (at least 20 mg omeprazole equivalent daily) as usual.