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

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis; Hypertension, Portal
• Intervention / Treatment: Drug: Proton Pump Inhibitors; Drug: 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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Department of Gastroenterology,QiLu Hospital,Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yanjing Gao
• Investigators: Principal Investigator: Yanjing /A Gao, PhD.MD, Qilu Hospital，Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: May 13, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Hemorrhage; Gastroesophageal varices
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Hypertension, Portal; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Proton Pump Inhibitors
• Other Study ID Numbers: 2017037-QILU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No