A Prospective Cohort Study to Study the Natural History and Ulcer Recurrence Without Acid Suppression of Non-NSAID, Non-HP Bleeding Peptic Ulcer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 391
- 试验地点
- 1
- 主要终点
- Recurrent ulcer bleeding
研究概览
简要总结
The aim of this study is to study the natural history of the ulcer healing while on proton pump inhibitors (PPI) and the ulcer recurrence without acid suppression therapy of Non-steroidal Anti-inflammatory Drugs (NSAID), non-Helicobacter pylori (HP) bleeding ulcer patients.
详细描述
Non-steroidal Anti-inflammatory Drugs (NSAID), Non-Helicobacter pylori (HP) bleeding peptic ulcers are relatively common in the West (11%-44%). It is uncommon in Hong Kong (4%). Significant number of these patients with non-NSAID, non-Hp bleeding ulcers had co-morbid illness and many had life-threatening conditions. Our recent study showed that there is an increasing incidence of non-steroidal anti-inflammatory drugs (NSAID), non-Helicobacter pylori (Hp) bleeding peptic ulcers. There is no datum on the natural course of these patients and this is our aim to have this observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient has non-NSAID (non-steroidal anti-inflammatory drugs), non-Helicobacter pylori bleeding peptic ulcer
- •Age > 18 years old
- •Informed consent
排除标准
- •Concommitant use of high dose steroid or warfarin
- •New start on non-steroidal anti-inflammatory drugs or aspirin or COX2 inhibitors
- •Renal failure (serum creatinine > 200umol/l)
- •Previous gastric surgery
- •Oesophagitis, esophageal varices
- •Terminal illness or malignancy
结局指标
主要结局
Recurrent ulcer bleeding
时间窗: During the observation period
Hematemesis or melena documented by the admitting physician, or a decrease in the hemoglobin level of at least 2 g/dL, with ulcers or bleeding erosions confirmed on endoscopy.
次要结局
- All-cause mortality(During the observation period)
研究者
Francis KL Chan
Professor
Chinese University of Hong Kong