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

Yanjing Gao

Status and phase: Completed; Phase 4

Conditions: Hypertension, Portal; Liver Cirrhosis

Treatments: Drug: Placebo; Drug: Proton Pump Inhibitors

Study type: Interventional

Funder types: Other

Identifiers

NCT03175731

2017037-QILU

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups, including a placebo group

Proton Pump Inhibitors

Experimental group

Description:

Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.

Treatment:

Drug: Proton Pump Inhibitors

Placebo

Placebo Comparator group

Description:

Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.

Treatment:

Drug: Placebo