Timing of Endoscopy in Cirrhotic Patients With Acute Variceal Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 368
- 试验地点
- 2
- 主要终点
- The failure to control bleeding after admissions
研究概览
简要总结
Endoscopy is important for the diagnosis and treatment of acute upper gastrointestinal bleeding (AUGIB), especially acute variceal bleeding (AVB), in patients with liver cirrhosis. However, the optimal timing of endoscopy remains controversial, primarily because the currently available evidence is of poor quality, and the definition of early endoscopy is also very heterogeneous among studies. Herein, a multicenter randomized controlled trial (RCT) is performed to explore the impact of timing of endoscopy on the outcomes of cirrhotic patients with AVB.
详细描述
A total of 368 cirrhotic patients presenting with AUGIB that is highly suspected to be from AVB will be enrolled. They will be stratified according to the severity of liver function and hemodynamic status at admission, and randomly assigned at a 1:1 ratio into early (within 12 hours after admission) and delayed (within 12-24 hours after admission) endoscopy groups within each stratum. The primary outcomes include the rates of 5-day failure to control bleeding after admission and 6-week rebleeding. The secondary outcomes include 6-week mortality and incidence of adverse events.
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
- None
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
- •patients with AUGIB which is highly suspected to be caused by gastroesophageal variceal rupture;
- •patients with a diagnosis of liver cirrhosis based on imaging and pathology;
- •patients and/or their relatives who sign informed consents;
- •patients' age ≥18 years.
排除标准
- •patients who have undergone endoscopy at other hospitals before admissions;
- •patients' hemodynamics are unstable after resuscitation;
- •patients with severe cardiovascular or cerebrovascular diseases or renal injury;
- •patients who have taken anticoagulants or antiplatelet drugs within 2 weeks before admissions, or are diagnosed with severe hematological diseases;
- •patients with human immunodeficiency virus or other acquired or congenital immune deficiency diseases;
- •patients with mental illness;
研究组 & 干预措施
Early endoscopy group
Intervention of endoscopy is within 12 hours after admission
干预措施: Endoscopy (Procedure)
Delayed endoscopy group
Intervention of endoscopy is within 12-24 hours after admission
干预措施: Endoscopy (Procedure)
结局指标
主要结局
The failure to control bleeding after admissions
时间窗: within 5 days admission
Failure to control bleeding is defined as any one of the three following conditions within 5 days admission: 1) vomiting of fresh blood; 2) suction of more than 100ml of fresh blood from the nasogastric tube; 3) a decrease in hemoglobin concentration of 30g/L in the absence of blood transfusion; or 4) death.
6-week rebleeding
时间窗: 6-week
Rebleeding is defined as new onset of hematemesis or melena after successful treatment.
次要结局
- 6-week all-cause mortality(6-week)
- Adverse events(up to 6 weeks)
研究者
Xingshun Qi
Director of Department of Gastroenterology
General Hospital of Shenyang Military Region