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

Phase 4

Completed

• Conditions: Liver Cirrhosis; Hypertension, Portal
• Interventions: Drug: Placebo; Drug: Proton Pump Inhibitors

• Registration Number: NCT03175731
• Lead Sponsor: Yanjing Gao

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-05-25
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-05
• Primary Completion: 2019-08-30
• Study Completion: 2019-08-30
• Status Verified: 2021-05
• Results First Submitted: 2021-05-13
• Results First Submitted QC: 2021-05-13
• Last Update Submitted: 2021-05-13
• Results First Posted: 2021-06-09
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
Proton Pump Inhibitors	Proton Pump Inhibitors	Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.

Primary Outcome Measures

Name	Time	Method
Variceal Bleeding Events	8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Mortality	8 weeks	Prognosis of esophagogastric variceal bleeding.
Adverse Eventsafter Endoscopic Therapy	8 weeks	Advers events caused by endoscopic therapy, including chest pain, dysphagia, fever and so on

Trial Locations

Locations (1)

Department of Gastroenterology,Qilu Hospital,Shandong University; 🇨🇳 Jinan, Shandong, China