Prevention of Esophageal Variceal Rebleeding
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 主要终点
- very early rebleeding
研究概览
简要总结
BACKGROUND: Previous studies showed that the combination of endoscopic therapy with vasoconstrictor is better than either vasoconstrictor or endoscopic therapy alone in achieving the successful hemostatsis of acute variceal bleeding. The rationale of using vasoconstrictor is to enhance the efficacy of hemostasis by endoscopic therapy. Nowadays, endoscopic variceal ligation (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of choice in the arresting of acute esophageal variceal hemorrhage. EVL alone can achieve hemotasis up to 97% even in cases of active variceal hemorrhage. However, early rebleeding due to ligation-induced ulcer may be encountered. It appears that prevention of esophageal ulcers and bleeding by a proton pump inhibitor may be more logical than using a vasoconstrictor after cessation of bleeding by EVL.
Thus, the investigators designed a controlled trial to compare the initial hemostasis, early rebleeding rate in cirrhotic patients presenting with acute variceal bleeding receiving either emergency EVL plus vasoconstrictor infusion or losec infusion for 5 days.
详细描述
Methods of treatment:
Group 1: Somatostatin 250μg slow bolus IV infusion followed by 250μg per hour (6mg/ 24 hours) or Terlipressin 2mg bolus was instituted on enrollment followed by 1mg per 6 hours for 5 days. The use of either somatostatin or glypressin was at the discretion of doctors in charge. Group 2: Pantoloc 20 mg intravenously per day was instituted on enrollment and continued for 5 days.
Definition of initial hemostasis:
Initial hemostasis was defined as achieving a 24h bleeding-free period within the first 48h after treatment together with stable vital signs based on Baveno consensus criteria.
Very early rebleeding was defined as: UGI bleeding occurred after initial hemostasis and within 5 days after enrollment. UGI bleeding was proven to be from 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The etiology of portal hypertension is cirrhosis.
- •Age ranges between 18-80 y/o.
- •Patients presenting with acute esophageal variceal bleeding proven by emergency endoscopy within 12 hours. (Acute esophageal variceal bleeding was defined as:
- •when blood was directly seen by endoscopy to issue from an esophageal varix (active bleeding) OR
- •when patients presented with red color signs on their esophageal varices with blood in esophagus or stomach and no other potential site of bleeding identified (inactive bleeding).
- •EVL is performed after confirmation of acute esophageal variceal bleeding. Enrollment time: Immediately after EVL is completed and variceal bleeding is arrested.
- •Exclusion criteria:
- •association with severe systemic illness, such as sepsis, COPD, uremia
- •association with gastric variceal bleeding
- •failure in the control of bleeding by emergency EVL
- •moribund patients, died within 12 hours of enrollment
- •Uncooperative
- •Ever received EIS, EVL within one month prior to index bleeding
- •Child-Pugh's scores > 10
排除标准
- 未提供
研究组 & 干预措施
Arm A
add pantoloc to reduce ulcer bleeding after banding ligation
干预措施: pantoloc (proton pump inhibitor) (Drug)
Arm B: ligation + terlipressin 1mg q6h
Arm B, intervention: ligation + terlipressin 1mg q6h
干预措施: terlipressin (vasoconstrictor) (Drug)
结局指标
主要结局
very early rebleeding
时间窗: 5 days
次要结局
- mortality, complications(42 days)