Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- The specific aim of this proposal will be: To assess the association between acid reflux and subepithelial fibroblasts in Barrett's esophagus.
研究概览
简要总结
Patients with Barrett's Esophagus are known to have excessive distal esophageal acid exposure comparable to patients with erosive esophagitis. A significant proportion of patients with BE who are not symptomatic on treatment continue to have persistent acid reflux. High dose esomeprazole is able to control acid reflux in patients with BE. The effect of acid reflux on Barrett's esophagus stroma is currently unknown.
It is our hypothesis that stromal fibroblast activation in Barrett's esophagus is influenced by acid reflux. The specific aim of this proposal will be: To assess the association between acid reflux and subepithelial fibroblasts in Barrett's esophagus.
详细描述
We will conduct a prospective cohort study to assess the degree of stromal activation in patients with LSBE (without dysplasia) who have adequate and inadequate control of acid reflux in the distal esophagus. The study will be conducted in two phases.
Phase 1 (Pilot): 20 patients with LSBE without dysplasia will undergo endoscopy with biopsies and a 24 hour pH study on treatment. Patients will then be divided into 2 groups:
- Group A (GER): Those with ongoing acid reflux (characterized by either presence of esophagitis [LA classification B,C or D1] on endoscopy, and/or a positive pH study on treatment defined using standard criteria)
- Group B (NGER): Those with controlled acid reflux (negative endoscopy and pH study on treatment).
Stromal markers that will be assessed and compared between the 2 groups will include: presence of activated myofibroblasts (detected by immunohistochemistry for vimentin and smooth muscle actin).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 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 cms
- •Absence of dysplasia on prior biopsies
- •Laboratory studies:
- •Prothrombin time (INR) < 1.5
- •Hemoglobin > 8.0 gm/dL
- •Ability to provide informed consent
排除标准
- •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. Although none of the procedures in the study are contraindicated in pregnancy, sedation used in endoscopy can be contraindicated in early pregnancy
- •Prior esophageal surgery, or cancer
结局指标
主要结局
The specific aim of this proposal will be: To assess the association between acid reflux and subepithelial fibroblasts in Barrett's esophagus.
时间窗: end of study
次要结局
未报告次要终点