Comparison of 24-hours Versus 72-hours of Octreotide Infusion Along With Endoscopic Therapy in Preventing Early Rebleed From Esophageal Varices: a Multi-center, Randomized Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 8
- 主要终点
- Esophageal Varices Rebleed Within 72-hours After Control of Initial Bleed
研究概览
简要总结
This study evaluates the safety and efficacy of 24-hour vs 72-hour octreotide infusion after variceal banding in cirrhotic patients with bleeding esophageal varices.
详细描述
In cirrhotic patients with bleeding esophageal varices, standard of care therapy includes administration of octreotide infusion over 72-hours and endoscopic banding of esophageal varices.
Octreotide acts to reduce the pressure in the blood vessels surrounding the liver, decreasing the propensity of bleeding from esophageal varices. The recommended duration of octreotide therapy is based largely on expert opinion, however a 72-hour duration of treatment is likely to be unnecessary and may inappropriately increase hospital and medical costs.
This study aims to determine the safety of 24-hours of octreotide infusion in patients with bleeding esophageal varices.
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
- •Adult males and females who are 18 years of age or older.
- •Evidence or suspicion of upper gastrointestinal bleed (GIB)
- •Patient with known or suspected cirrhosis
- •Upper GIB secondary to bleeding esophageal varices as show by esophageal endoscopy, requiring endoscopic band ligation (EBL) at presentation
- •Willing and able to provide informed consent for study, or have a Legally authorized representative (LAR) provide consent if the patient is unable to do so
排除标准
- •Known upper gastrointestinal malignancy
- •Bleeding from gastric varices, with or without esophageal varices
- •Use of any other endoscopic method to stop GI bleeding beyond endoscopic band ligation
- •Variceal bleeding in the last 90 days
- •History of transjugular, intrahepatic, portosystemic shunt (TIPS) or vascular decompression surgery
- •Pregnant females
- •Incarcerated individuals
- •Myocardial infarct, cerebrovascular accident, sepsis, respiratory failure, or severe intercurrent illness within the previous 6 weeks
- •Non-cirrhotic portal hypertension causing esophageal varices
- •Known or suspected allergy to octreotide
研究组 & 干预措施
24-hour octreotide infusion
Patients will receive octreotide infusion over 24 hours
干预措施: Octreotide (Drug)
72-hour octreotide infusion
Patients will receive octreotide infusion over 72 hours
干预措施: Octreotide (Drug)
结局指标
主要结局
Esophageal Varices Rebleed Within 72-hours After Control of Initial Bleed
时间窗: 72 hours
Rebleeding within 72-hours will be defined as any of the following: 1. A drop in hemoglobin by more than 20 percentage points from baseline 2. Sustained tachycardia above 100 beats per minute, with or without hematochezia or melena 3. Transfusion of \>2 unites packed red blood cells after esophageal band ligation 4. Recurrence of hematemesis or ongoing melena 5. Urgent or emergent need for Transjugular Intrahepatic Portosystemic Shunt (TIPS) to control suspected rebleeding
次要结局
- Esophageal Varices Rebleed at 7 Days and 30 Days After Control of Initial Bleed(7 days and 30 days)
- Survival at 7 Days and 30 Days After Control of Initial Bleed(7 days and 30 days)