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

NCT03175731 | Completed Phase 4 Results DMC

• 1 other identifier: 2017037-QILU
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Hypertension, Portal

Keywords

Gastroesophageal varices; Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mortality

  8 weeks

• Adverse Eventsafter Endoscopic Therapy

  8 weeks

Study Arms (2)

Proton Pump Inhibitors

EXPERIMENTAL

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

Drug: Proton Pump Inhibitors

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Proton Pump Inhibitors DRUG

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

Also known as: Experimental

Proton Pump Inhibitors

Placebo DRUG

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

Also known as: Control

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of cirrhosis
• GEVs was diagnosed by endoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Yanjing Gao: lead

Study Sites (1)

Department of Gastroenterology,Qilu Hospital,Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal; Hemorrhage

Interventions

Proton Pump Inhibitors

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Prof. Gao
• Organization: Qilu Hospital of Shandong University

gaoyanjing@sdu.edu.cn

+86-531-82169386

Study Officials

• Yanjing /A Gao, PhD.MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice presidengt of Department of Gastroenterology of Qilu Hospital

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: June 5, 2017
• Study Start: May 1, 2017
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: June 9, 2021
• Results First Posted: June 9, 2021

Record last verified: 2021-05

Locations

CN (1)