Potassium-competitive Acid Blocker Versus Double Dose Proton Pump Inhibitors in High High-risk Peptic Ulcer Bleeding: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 108
- 主要终点
- Recurrent bleeding
研究概览
简要总结
This randomized clinical trial will enroll patients at National Cheng Kung University Hospital who have upper gastrointestinal ulcer bleeding, have undergone endoscopic hemostasis, and have a Rockall score of 6 or higher.
A total of 108 patients will be enrolled and randomly assigned to two groups: Standard-treatment group: 54 patients, Experimental group: 54 patients.
Both groups will receive standard endoscopic hemostasis and 72 hours of intravenous PPI therapy. Thereafter, patients in the standard-treatment group will receive double-dose PPI therapy, whereas patients in the experimental group will receive a P-CAB per day. All patients will be followed for 28 days to assess the occurrence of rebleeding.
详细描述
Upper gastrointestinal bleeding is a common clinical condition associated with a substantial risk of mortality, with ulcer bleeding accounting for the majority of cases. Current standard treatment consists of pharmacological therapy combined with endoscopic hemostasis. Pharmacological therapy suppresses gastric acid secretion, reduces clot dissolution, and creates an environment conducive to mucosal healing.
Various scoring systems are used clinically to assess disease severity and prognosis in patients with ulcer bleeding. The Rockall score is one of the most commonly used systems. Patients with a Rockall score of 6 or higher have a higher risk of rebleeding and mortality. Therefore, high-risk patients are generally treated with twice-daily oral proton pump inhibitors (PPIs). However, twice-daily dosing may reduce medication adherence.
Potassium-competitive acid blockers (P-CABs) have emerged in recent years and offer several potential advantages, including rapid onset of action, potent acid suppression, stability in an acidic environment, and a long half-life. They may represent a new treatment option for peptic-ulcer disease. This study will therefore compare the efficacy of PPI and P-CAB therapy in preventing recurrent bleeding among patients with upper gastrointestinal ulcer bleeding and a Rockall score of 6 or higher.
This randomized clinical trial will enroll patients at National Cheng Kung University Hospital who have upper gastrointestinal ulcer bleeding, have undergone endoscopic hemostasis, and have a Rockall score of 6 or higher.
A total of 108 patients will be enrolled and randomly assigned to two groups: Standard-treatment group: 54 patients, Experimental group: 54 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Hospitalized patients > 18 years with upper gastrointestinal ulcer bleeding, a Rockall score of 6 or higher, and treatment with endoscopic hemostasis.
排除标准
- •history of hypersensitivity to PPIs or P-CABs.
- •non-ulcer-related bleeding, such as variceal bleeding, angiodysplasia, diverticular bleeding, diffuse mucosal bleeding, or tumor bleeding.
- •severe hepatic or renal impairment
结局指标
主要结局
Recurrent bleeding
时间窗: 28 days
If melena or hematochezia occurs during follow-up, endoscopy will be performed to determine whether recurrent bleeding originates from the original bleeding lesion.
次要结局
- Requirement for transcatheter arterial embolization or surgical hemostasis because of recurrent bleeding(28 days)
- Mortality(28 days)
研究者
Hsueh-Chien Chiang
Attending Physician
National Cheng-Kung University Hospital