Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- activated myofibroblasts
研究概览
简要总结
The purpose of this study is to determine the association between acid reflux and cell changes in Barrett's esophagus.
Specific aim 1: To test the hypothesis that controlled acid reflux is associated with lesser degree of stromal activation.
Specific aim 2: To test the hypothesis that stromal fibroblast derived growth factors drive BE epithelial proliferation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior histological demonstration of Barrett's esophagus that is endoscopically visible; length of visible segment >/= 1 cm
- •Absence of dysplasia or LGD on biopsies within the past 5 years
- •Ability to provide informed consent
- •Age between 18 years and 90 years at study entry.
- •Exclusion criteria:
- •Eastern Cooperative Oncology Group performance status 3 or 4
- •Inability to tolerate endoscopic procedures
- •Pregnancy: Females of child-bearing age will be screened with pregnancy test.
- •Prior esophageal surgery, or cancer
排除标准
- 未提供
结局指标
主要结局
activated myofibroblasts
时间窗: 6 months
The primary end point for the study will be the proportion of patients with activated myofibroblasts (defined as positive staining for SMA and vimentin with negative staining for Desmin, in \> 50% of subepithelial myofibroblasts). This primary end point will be compared between the group with controlled acid reflux and the group without acid reflux.
次要结局
未报告次要终点