Trial | NCT03175731  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Study Participants

    106
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.
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 Started
May 01
2017
Primary Completion
Aug 30
2019
Study Completion
Aug 30
2019
Results Posted
Jun 09
2021
Last Update
Jun 09
2021

Drug Proton Pump Inhibitors [esomeprazole (nexium), pantoprazole (protonix)]

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

  • Other names: Experimental

Drug Placebo

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

  • Other names: Control

Proton Pump Inhibitors Experimental

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

Placebo Placebo Comparator

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

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

Summary

Proton Pump Inhibitors

Placebo

All Events

Event Type Organ System Event Term Proton Pump Inhibitors Placebo

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.

Proton Pump Inhibitors

Placebo

Mortality

Prognosis of esophagogastric variceal bleeding.

Proton Pump Inhibitors

Placebo

Adverse Eventsafter Endoscopic Therapy

Advers events caused by endoscopic therapy, including chest pain, dysphagia, fever and so on

Proton Pump Inhibitors

Placebo

Total

106
Participants

Age, Continuous

53.8
years (Mean)
Standard Deviation: 10.2

Race and Ethnicity Not Collected

0
Participants

Region of Enrollment

Sex: Female, Male

Overall Study

Proton Pump Inhibitors

Placebo