High Dose Oral Omeprazole Versus Standard Continuous Intravenous Pantoprazole in Patient With Peptic Ulcer Bleeding and Undergo Successful Therapeutic Endoscopy; Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Rate of 3-day peptic ulcer rebleeding
研究概览
简要总结
Peptic ulcer bleeding is the most common etiology in upper gastrointestinal bleeding all over the world. After endoscopic treatment, proton pump inhibitor (PPI) is recommended to prevent re-bleeding. Intravenous PPI is recommended as a standard treatment. In the past, there were many trials showing the efficacy of high-dose oral PPI after endoscopic hemostasis but most were industrial sponsor which assessing an expensive PPI. Moreover, the number of patients in those studies were insufficient to confirm a non-inferiority outcome in term of rebleeding by using oral PPI. This study will evaluate a high-dose, local-made PPI (omeprazole) in peptic ulcer treatment after successful endoscopic hemostasis compared to standard IV PPI continuous drip in term of rebleeding, as well as 24-hour gastric pH monitoring.
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)
盲法说明
The outcomes assessor will not know the assigned treatment.
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 peptic ulcer bleeding and endoscopic finding show ulcer with Forrest classification Ia (spurting haemorrhage), IIa (oozing haemorrhage), Ib (non-bleeding visible vessel)
- •Age > 18 years old
排除标准
- •Deny to participate
- •Pregnancy or lactation
- •Low risk peptic ulcer bleeding including clean base ulcer, flat pigmented spot
- •Non-peptic ulcer bleeding eg. erosive gastritis/duodenitis, Mallory Weiss tear, esophageal/gastric/duodenal varices, vascular lesions (eg. Dieulafoy) , malignant ulcer
- •Bleeding tendency
- •Terminal stage of cancer
- •ESRD on hemodialysis
- •Decompensated liver cirrhosis
研究组 & 干预措施
High-dose oral PPI
Omeprazole 80 mg/day (40 mg twice a day) per oral route for 72 hours
干预措施: High-dose oral omeprazole (Drug)
Standard IV PPI
Pantoprazole 8 mg/hour IV continuous drip for 72 hours
干预措施: Standard IV PPI (Drug)
结局指标
主要结局
Rate of 3-day peptic ulcer rebleeding
时间窗: 3 days
次要结局
- Percentage of 24-hour gastric pH above 6(3 days)
- Rate of 30-day peptic ulcer rebleeding(30 days)
研究者
Rapat Pittayanon
Principle investigator, Gastrointestinal Unit
King Chulalongkorn Memorial Hospital
