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

NCT ID: NCT03175731

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2019-08-30

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.

Conditions

Liver Cirrhosis; Hypertension, Portal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Proton Pump Inhibitors

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

Group Type: EXPERIMENTAL

Proton Pump Inhibitors

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Proton Pump Inhibitors

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Experimental; Control

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yanjing Gao

OTHER

Sponsor Role: lead

Responsible Party

Yanjing Gao

Vice presidengt of Department of Gastroenterology of Qilu Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yanjing /A Gao, PhD.MD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital, Shandong University

Locations

Department of Gastroenterology,Qilu Hospital,Shandong University

Jinan, Shandong, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017037-QILU

Identifier Type: -

Identifier Source: org_study_id