High Dose Versus Standard Dose Proton Pump Inhibitor in High-risk Bleeding Peptic Ulcers After Combined Endoscopic Hemostasis: A Prospective Randomized Comparative Study
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- rate of initial hemostasis and the rate of recurrent bleeding
研究概览
简要总结
The study was designed to evaluate the efficacy an adjuvant use of standard dose or high dose of proton pump inhibitor after combined endoscopic hemostasis therapy.
详细描述
Acute peptic ulcer bleeding remains the most common cause of acute upper gastrointestinal bleeding. Endoscopy serves as a tool for initial diagnosis and triage and also a tool for immediate hemostasis, especially for high-risk lesions. High-risk lesions include peptic ulcers with active spurting vessel, oozing vessel, or NBVV, nonbleeding visible vessel. Current modalities of endoscopic hemostasis include epinephrine injection, endoscopic coaptive thermocoagulation, hemoclipping. Endoscopic hemostasis has been documented by a number of clinical studies to be effective in decreasing rebleeding, need for emergency surgery, decreasing hospitalization days. Current evidence also shows that combination therapy with epinephrine injection and heater probe thermocoagulation/hemo-clip hemostasis is more effective than epinephrine injection alone or than heater probe thermocoagulation alone, or than hemoclip hemostasis alone. Studies showed a high dose intravenous proton pump inhibitor infusion after initial endoscopic hemostasis reduced recurrent ulcer bleeding. However, it was still controversial whether an adjuvant use of standard-dose proton pump inhibitor therapy to endoscopic therapy had similar benefit. We hypothesized that an adjuvant use of standard dose of proton pump inhibitor after combined endoscopic hemostasis therapy offer similar benefit as high dose proton pump inhibitor did.
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 (Participant)
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults aged above 16 years old with acute nonvariceal upper gastrointestinal bleeding
- •read, agree to attend the study, and signed informed consent indicated to receive esophagogastroduodenoscopy(EGD)
- •peptic ulcers with high risk lesions (active bleeding: spurting, oozing peptic ulcers. Ulcers with NBVV: nonbleeding visible vessel)
排除标准
- •unable to receive EGD (unable to open mouth, upper gastrointestinal obstruction)
- •bleeding tendency (platelet < 50x109/L, prothrombin time INR >2, ongoing use of heparin or coumadin)
- •gastric malignancy
- •myocardial infarction within recent one week
- •recent cerebrovascular event within recent one week
- •pregnancy
- •refuse to attend the study
- •known allergy history to epinephrine or pantoprazole
研究组 & 干预措施
1
High dose pantoprazole infusion
干预措施: High dose pantoprazole infusion (Drug)
2
standard dose pantoprazole infusion
干预措施: Standard dose pantoprazole infusion (Drug)
结局指标
主要结局
rate of initial hemostasis and the rate of recurrent bleeding
时间窗: 72hr
次要结局
- need for surgical intervention to control bleeding, transfusion requirements, length of hospital stay (in days), and 30-day mortality(30day)
