Effect of Helicobacter Pylori Eradication on the Reversibility of Atrophic Gastritis and Intestinal Metaplasia in Korean Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,450
- 试验地点
- 1
- 主要终点
- The improvement of Atrophic Gastritis and Intestinal metaplasia score
研究概览
简要总结
Helicobacter pylori (H. pylori) infection has been associated with a development of atrophic gastritis and intestinal metaplasia. H. pylori related atrophic gastritis and intestinal metaplasia have been regarded as pre-malignant lesion. However, the role of H. pylori eradication treatment in the reversibility of atrophic gastritis and intestinal metaplasia has not been clearly defined. The aim of the present study was to investigate the relationship between H. pylori eradication and the reversibility of atrophic gastritis and intestinal metaplasia in Korean patients.
详细描述
It is a prospective, case-control study to compare the status of atrophic gastritis and intestinal metaplasia from the patients who undergo H. pylori eradication treatment or not. After enrollment, each patient will be receive annual surveillance upper gastrointestinal endoscopy. The present investigators will monitor the status of atrophic gastritis and intestinal metaplasia annually and finally compare the reversibility of them.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Patients who diagnosis of H. pylori infection
- •Patients presenting with H. pylori related gastrointestinal disease and/or
- •Patients do not have H. pylori related gastrointestinal disease. But, want H. pylori eradication
排除标准
- •Age under 18 years Previous eradication treatment for H. pylori Patients who took any drug which could influence the study results such as proton pump inhibitor, antibiotics within 4 weeks History of gastrectomy Advanced gastric cancer or other malignancy Abnormal liver function or liver cirrhosis Abnormal renal function or chronic kidney disease Other severe concurrent diseases Previous allergic reactions to the study drugs Pregnant or lactating women
结局指标
主要结局
The improvement of Atrophic Gastritis and Intestinal metaplasia score
时间窗: per 1 year
The improvement of Atrophic Gastritis and Intestinal metaplasia was defined as improvement of score compared with baseline. The histological features of the gastric mucosa were recorded using updated Sydney system scores, that is, 0 = none, 1 = mild, 2 = moderate, and 3 = marked.(Am J Surg Pathol 1996;20:1161-81.) Outcome measure will be done annually (per 1 year), final follow-up is 2019
次要结局
未报告次要终点
研究者
Nayoung Kim
Professor
Seoul National University Bundang Hospital