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Deprescribing Proton Pump Inhibitors to Reduce Post-TIPS Hepatic Encephalopathy

Primary Purpose

Hepatic Encephalopathy

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PPI deprescribing
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatic Encephalopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Duke University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PPI deprescribing arm

PPI continuation arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Minimal hepatic encephalopathy
Minimal hepatic encephalopathy, as assessed by psychometric hepatic encephalopathy score

Secondary Outcome Measures

Per-protocol evaluation of minimal hepatic encephalopathy
Minimal hepatic encephalopathy, as assessed by psychometric hepatic encephalopathy score, based on actual reported PPI use
Chronic liver disease specific quality of life
Chronic liver disease (CLDQ) specific QOL assessment
Gastroesophageal reflux specific quality of life
Gastroesophageal reflux (QOLRAD) specific QOL assessment
Overt hepatic encephalopathy
Episodes of overt hepatic encephalopathy (defined as West-Haven grade 2 or greater)
On-demand requirement for acid suppression therapy
Proportion of patients in the PPI discontinuation arm needing on-demand H2 blockers or PPIs for gastroesophageal reflux symptoms
Adverse events
Adverse events in the PPI continuation versus discontinuation arms

Full Information

First Posted
September 27, 2021
Last Updated
January 23, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT05070351
Brief Title
Deprescribing Proton Pump Inhibitors to Reduce Post-TIPS Hepatic Encephalopathy
Official Title
A Randomized Open-label Trial of Deprescribing Proton Pump Inhibitors to Reduce the Risk of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt Creation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PPI deprescribing arm
Arm Type
Experimental
Arm Description
Patients taking a PPI (at least 20 mg omeprazole equivalent daily) will be instructed to stop taking their PPI.
Arm Title
PPI continuation arm
Arm Type
No Intervention
Arm Description
Patients will be instructed to continue taking their PPI (at least 20 mg omeprazole equivalent daily) as usual.
Intervention Type
Drug
Intervention Name(s)
PPI deprescribing
Intervention Description
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 Outcome Measure Information:
Title
Minimal hepatic encephalopathy
Description
Minimal hepatic encephalopathy, as assessed by psychometric hepatic encephalopathy score
Time Frame
Approximately 6-8 weeks
Secondary Outcome Measure Information:
Title
Per-protocol evaluation of minimal hepatic encephalopathy
Description
Minimal hepatic encephalopathy, as assessed by psychometric hepatic encephalopathy score, based on actual reported PPI use
Time Frame
Approximately 6-8 weeks
Title
Chronic liver disease specific quality of life
Description
Chronic liver disease (CLDQ) specific QOL assessment
Time Frame
Approximately 6-8 weeks
Title
Gastroesophageal reflux specific quality of life
Description
Gastroesophageal reflux (QOLRAD) specific QOL assessment
Time Frame
Approximately 6-8 weeks
Title
Overt hepatic encephalopathy
Description
Episodes of overt hepatic encephalopathy (defined as West-Haven grade 2 or greater)
Time Frame
Approximately 6-8 weeks
Title
On-demand requirement for acid suppression therapy
Description
Proportion of patients in the PPI discontinuation arm needing on-demand H2 blockers or PPIs for gastroesophageal reflux symptoms
Time Frame
Approximately 6-8 weeks
Title
Adverse events
Description
Adverse events in the PPI continuation versus discontinuation arms
Time Frame
Approximately 6-8 weeks
Other Pre-specified Outcome Measures:
Title
Change in gastrointestinal tract microbiome
Description
Pre-TIPS to post-TIPS change in stool taxon abundances as measured by 16S rRNA sequencing
Time Frame
Approximately 6-8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Ronald, MD PhD
Phone
919-684-7299
Email
james.ronald@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Ronald, MD PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Research Coordinator
Phone
919-684-7810
Email
latonia.strader@duke.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Deprescribing Proton Pump Inhibitors to Reduce Post-TIPS Hepatic Encephalopathy

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