跳至主要内容
临床试验/NCT02688114
NCT02688114已完成不适用

Healing of the Esophageal Mucosa After Radiofrequency Ablation of Barrett's Esophagus

Dallas VA Medical Center4 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2017年10月18日最近更新:
适应症

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

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

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Stuart Spechler

Chief, Division of Gastroenterology

Dallas VA Medical Center

研究点 (4)

Loading locations...

相似试验