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Completed

NCT Number: NCT03175731

PPIs and Gastroesophageal Varices 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.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Hemorrhage Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Gastroenterology,Qilu Hospital,Shandong University

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proton Pump Inhibitors

Drug

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

Other names: Experimental

Placebo

Drug

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

Other names: Control

Primary outcomes

  1. Variceal Bleeding Events

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Mortality

    Time frame: 8 weeks

    Prognosis of esophagogastric variceal bleeding.

  2. Adverse Eventsafter Endoscopic Therapy

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

Yanjing Gao

Other

Registry information

Official study title

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

Acronym: PPIs

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 5, 2017
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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