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Completed

NCT Number: NCT05070351

Deprescribing Proton Pump Inhibitors to Reduce Post-TIPS Hepatic Encephalopathy

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.

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Key information

Conditions

Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Duke University Hospital

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PPI deprescribing

Drug

Patients currently on a proton pump inhibitor (PPI) undergoing transjugular intrahepatic portosystemic shunt (TIPS) creation as part of routine clinical care will be randomized to receive instructions to stop taking their PPI.

Primary outcomes

  1. Minimal hepatic encephalopathy

    Time frame: Approximately 6-8 weeks

    Minimal hepatic encephalopathy, as assessed by psychometric hepatic encephalopathy score

Secondary outcomes

  1. Per-protocol evaluation of minimal hepatic encephalopathy

    Time frame: Approximately 6-8 weeks

    Minimal hepatic encephalopathy, as assessed by psychometric hepatic encephalopathy score, based on actual reported PPI use

  2. Chronic liver disease specific quality of life

    Time frame: Approximately 6-8 weeks

    Chronic liver disease (CLDQ) specific QOL assessment

  3. Gastroesophageal reflux specific quality of life

    Time frame: Approximately 6-8 weeks

    Gastroesophageal reflux (QOLRAD) specific QOL assessment

  4. Overt hepatic encephalopathy

    Time frame: Approximately 6-8 weeks

    Episodes of overt hepatic encephalopathy (defined as West-Haven grade 2 or greater)

  5. On-demand requirement for acid suppression therapy

    Time frame: Approximately 6-8 weeks

    Proportion of patients in the PPI discontinuation arm needing on-demand H2 blockers or PPIs for gastroesophageal reflux symptoms

  6. Adverse events

    Time frame: Approximately 6-8 weeks

    Adverse events in the PPI continuation versus discontinuation arms

Other outcomes

  1. Change in gastrointestinal tract microbiome

    Time frame: Approximately 6-8 weeks

    Pre-TIPS to post-TIPS change in stool taxon abundances as measured by 16S rRNA sequencing

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

A Randomized Open-label Trial of Deprescribing Proton Pump Inhibitors to Reduce the Risk of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt Creation

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 7, 2021
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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