Timing of Upper Endoscopy in Cirrhotic Patients With Upper Gastrointestinal Bleeding: Urgent vs. Elective Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- in-hospital bleeding
研究概览
简要总结
Liver cirrhosis is a common diffuse and persistent liver disease often accompanied by portal hypertension, liver failure, upper gastrointestinal bleeding (UGIB), and other complications. The incidence rate of liver cirrhosis with UGIB is as high as 30-40%, which is related to the rupture bleeding of gastroesophageal varices (GOV), hepatogenic ulcer, portal hypertensive gastropathy, hepatic gastrointestinal failure, etc
详细描述
In the case of UGIB in patients with liver cirrhosis, acute peripheral circulatory failure may suddenly occur, resulting in decreased blood perfusion in liver tissues, often accompanied by clinical manifestations such as blood volume decline, melena, and haematemesis. This disease progresses rapidly, with a mortality rate of above 10% if not treated promptly
Timing of endoscopy in the management of acute upper gastrointestinal bleeding (AUGIB) has been a subject of perennial debate. Despite remarkable advancements in endoscopic treatments and substantial efforts in reducing mortality, the overall in-hospital mortality rate associated with UGIB is still estimated to be 10%.
Several studies have investigated the clinical impact of urgent (within 6 h of presentation) or early (within 12 h) endoscopy on mortality in patients with UGIB. Some studies showed no significant difference in mortality rate between urgent and elective endoscopy groups among high-risk patients with acute UGIB
In contrast, others found that urgent endoscopy was associated with a lower mortality rate in high-risk patients with acute non-variceal UGIB. Most of the previous studies included highly selected patients with non-variceal UGIB or those at a high risk. However, given that the definitive diagnosis is made after endoscopic examination, these studies may not reflect real-world clinical practice. Furthermore, it is often challenging to predict the cause of bleeding and to identify patients at high risk who require intensive care based on their symptoms and the information obtained in the emergency room
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
Patient will be enrolled in one each group without masking
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
- •Any patient who is above age of 18 years old and with liver cirrhosis and present with UGIB will be eligible for the study
排除标准
- •Patients with age less than 18 years old
- •Non-cirrhotic patients
- •Patients with hemodynamic instability
- •Patient's refusal
结局指标
主要结局
in-hospital bleeding
时间窗: One year
Frequency of mortality in patients with variceal bleeding
次要结局
未报告次要终点
研究者
Shadn Ahmed Keilany
Principal Investigator
Assiut University
