Phase 4
N=106
PPIs and Gastroesophageal Varices in Liver Cirrhosis (PPIs: Proton Pump Inhibitors)
Liver Cirrhosis · Hypertension, Portal
Bottom Line
View on ClinicalTrials.gov: NCT03175731 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Variceal Bleeding Events — 3; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Proton Pump Inhibitors (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yanjing Gao
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Variceal Bleeding Events |
3; 3 | — |
| SECONDARY Mortality |
1; 0 | — |
| SECONDARY Adverse Eventsafter Endoscopic Therapy |
15; 20 | — |
Summary
This study is aimed at investigating the effect of PPIs on gastroesophageal varices in liver cirrhosis. Half of participants will receive PPI, while the other half will receive a placebo.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of cirrhosis
- GEVs was diagnosed by endoscopy
Exclusion Criteria
- Acute gastrointestinal bleeding need emergency surgery
- Acid-related disease, such as peptic ulcer disease or gastroesophageal reflux diseases (GERD)
- Hepatocellular carcinoma (HCC) or other malignant tumor
- History of esophagus, stomach or liver surgery
- Child-Pugh C and can't be improved to Child-Pugh A or B
- Preparing to be pregnant, pregnant or breast feeding
- Allergic to PPIs(proton pump inhibitors) or intolerable
- Cannot provide informed consent
Data sourced from ClinicalTrials.gov (NCT03175731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.