PPIs and Gastroesophageal Varices in Liver Cirrhosis (PPIs: Proton Pump Inhibitors)

Study Overview
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Brief Summary
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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.

Detailed Description
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PPIs can inhibit parietal cell H+/K+-ATPase and reduce secretion of gastric acid. PPIs can promote platelet aggregation and stabilize the formation of fibrin thrombosis by maintaining the high pH environment in the stomach and inactivating pepsin. The effect of PPIs on ulcerative upper gastrointestinal bleeding was confirmed but it is not clear whether PPIs is applicable in esophagogastric variceal bleeding whose etiology and bleeding position are different from ulcerative upper gastrointestinal bleeding. There is lack of consensus and sufficient evidences to support to use PPIs in esophagogastric variceal bleeding in cirrhotic patients universally. Nevertheless, the use of PPIs in liver cirrhotic patients with gastroesophageal varices is common.

Official Title
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A Randomized Controlled Study on the Effects of PPIs on Gastroesophageal Variceal Bleeding in Liver Cirrhosis (PPIs: Proton Pump Inhibitors)

Conditions
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Liver Cirrhosis, Hypertension, Portal

Intervention / Treatment
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* Drug: Proton Pump Inhibitors
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proton Pump Inhibitors<br>Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. | Drug: Proton Pump Inhibitors<br>* Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.<br>* Other names: Experimental;|
| Placebo Comparator: Placebo<br>Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. | Drug: Placebo<br>* Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variceal Bleeding Events | The primary endpoint was variceal bleeding, which was defined as hematemesis or melena from endoscopically proven GEVs, in the absence of any other lesion that might explain the bleeding. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Prognosis of esophagogastric variceal bleeding. | 8 weeks | 
| Adverse Eventsafter Endoscopic Therapy | Advers events caused by endoscopic therapy, including chest pain, dysphagia, fever and so on | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal varices, Hemorrhage