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

Liver Cirrhosis Clinical Trial

— PPIs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175731
• Other study ID #: 2017037-QILU
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: May 2021
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Hypertension, Portal
• Liver Cirrhosis

Intervention

Drug:
• Proton Pump Inhibitors
Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
• Placebo
Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.

Locations

Country	Name	City	State
China	Department of Gastroenterology,Qilu Hospital,Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Yanjing Gao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality	Prognosis of esophagogastric variceal bleeding.	8 weeks
Secondary	Adverse Eventsafter Endoscopic Therapy	Advers events caused by endoscopic therapy, including chest pain, dysphagia, fever and so on	8 weeks