A Randomized Controlled Study on the Effects of PPIs on Gastroesophageal Variceal Bleeding in Liver Cirrhosis (PPIs: Proton Pump Inhibitors)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Variceal Bleeding Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of cirrhosis
- •GEVs was diagnosed by endoscopy
排除标准
- •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
研究组 & 干预措施
Proton Pump Inhibitors
Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
干预措施: Proton Pump Inhibitors (Drug)
Placebo
Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Variceal Bleeding Events
时间窗: 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.
次要结局
- Mortality(8 weeks)
- Adverse Eventsafter Endoscopic Therapy(8 weeks)
研究者
Yanjing Gao
Vice presidengt of Department of Gastroenterology of Qilu Hospital
Qilu Hospital of Shandong University