The Impacts of On-demand Versus Continuous Esomeprazole Therapy on the Symptom Control and Histological Changes of Metaplastic Esophageal Epithelium in Patients With Barrett's Esophagus (EsoBE) - a Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 主要终点
- Rates of progression, remaining unchanged, or regression of the distal esophageal metaplastic mucosa in both groups after 48 weeks
研究概览
简要总结
On-demand PPI therapy is feasible for the long-term treatment of patients with Barrett's esophagus.
详细描述
Consecutive patients with symptomatic Barrett's esophagus are recruited and receive biopsy for esophageal metaplastic mucosa and gastric mucosa over the antrum and body during endoscopy on enrollment. The biopsy protocol for esophageal metaplastic mucosa is following Seattle protocol. GERD Q score will be conducted on enrollment. Additionally, blood sampling for CYP2C19 genotyping is also conducted on enrollment. The eligible subjects will be treated by 8-week esomeprazole, and are then randomly assigned to receive either maintenance or on-demand esomeprazole therapy (40 mg q.d.) for 40 weeks. The patients were asked to come back every four weeks for the recording of symptom days and PPI tablet consumption numbers. Follow-up endoscopy with biopsy for esophageal and gastric mucosa is performed at the end of the 48th weeks. We will compare the effects of maintenance and on-demand PPI therapy on (1) histological changes of esophageal metaplastic mucosa (2) symptom control (3) tablet consumption number
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients between the ages of 20 and 80 years
- •having symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach
- •having Barrett's Esophagus proven by histology confirmation
- •length of esophageal metaplastic mucosa equal to or longer than 1 centimeter
排除标准
- •pregnancy,
- •coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia)
- •previous gastric surgery,
- •allergic to esomeprazole,
- •presence of dysplastic esophageal mucosa
- •equivocal endoscopic diagnosis of Barrett's esophagus
研究组 & 干预措施
On-demand PPI therapy
The patients in this group were advised to take PPI for 8 weeks continuously, followed by on-demand PPI therapy for the following 40 weeks.
干预措施: Esomeprazole 40mg (Drug)
Continuous PPI therapy
The patients in this group were advised to take PPI QD continuously for 48 weeks.
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Rates of progression, remaining unchanged, or regression of the distal esophageal metaplastic mucosa in both groups after 48 weeks
时间窗: 48 weeks.
Progression, stationary, regression
Total symptom day
时间窗: 48 weeks
Days with reflux symptoms
Number of tablets consumed
时间窗: 48 weeks
PPI tablets consumed during follow-up
次要结局
未报告次要终点
研究者
Sung-shuo Kao
Principal Investigator
Kaohsiung Veterans General Hospital.