Healing of the Esophageal Mucosa After Radiofrequency Ablation of Barrett's Esophagus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- Change in the Percent of Mucosa Healed by Neosquamous Epithelium
研究概览
简要总结
Radiofrequency ablation (RFA) is a mainstay of treatment for patients who have Barrett's esophagus (BE) with dysplasia. For unclear reasons, Barrett's esophagus recurs after successful RFA treatment in approximately 1/3 of patients. The aim of this study is to characterize the healing process of the esophageal mucosa, histologically and at the molecular level, after RFA for non-dysplastic and dysplastic Barrett's esophagus.
详细描述
Radiofrequency ablation (RFA) is a mainstay of treatment for patients who have Barrett's esophagus (BE) with dysplasia. For unclear reasons, Barrett's esophagus recurs after successful RFA treatment in approximately 1/3 of patients. Little is known of how the esophagus heals after RFA treatment, and a better understanding of this healing process might provide insights into how to prevent Barrett's metaplasia from recurring after successful ablation.
The aim of this study is to characterize the healing process of the esophageal mucosa, histologically and at the molecular level, after RFA for non-dysplastic and dysplastic Barrett's esophagus. Patients with Barrett's esophagus will undergo surveillance endoscopy with biopsy. This will be followed by RFA treatment of the BE and follow up endoscopy will be performed 1, 2, and 4 weeks after RFA. Healing at each time point will be assessed endoscopically, and molecular markers related to healing will be studied. Stem cell expression markers, immune cells and markers of epithelial-mesenchymal transition will be compared with baseline expression for each patient. Protocol has been modified to provide a collaborative effort between the Dallas VAMC and Baylor Scott & White Medical Center in Dallas, TX. Veteran participants electing to participate will receive initial screening and endoscopy at the Dallas VAMC and will continue with RFA and follow-up endoscopies at Baylor. An identical protocol has been approved at Baylor Scott & White Medical center. Patients who are screened and enrolled at Baylor will receive all treatments at that location.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Barrett's esophagus
排除标准
- •inability to provide informed consent
- •esophageal varices
- •treatment with warfarin
- •coagulopathy that precludes safe biopsy of the esophagus (including platelet count <100,000/mm3, INR (international normalized ratio) >1.5)
- •allergy to fluorescein sodium
- •comorbidity that precludes safe participation in the study
- •pregnancy or breastfeeding status
结局指标
主要结局
Change in the Percent of Mucosa Healed by Neosquamous Epithelium
时间窗: 1 week, 2 weeks, 4 weeks
% of the esophageal mucosa healed by Neosquamous epithelium at 1 week, 2 weeks, and 4 weeks after RFA
次要结局
- Change in expression of genes associated with epithelial-mesenchymal transition, stem cells, and submucosal glands(1 week, 2 weeks, 4 weeks)
- Change in inflammatory cell infiltrate(1 week, 2 weeks, 4 weeks)
研究者
Stuart Spechler
Chief, Division of Gastroenterology
Dallas VA Medical Center
