Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Correlation between the time from intravenous injection of fluorescein to visualization of fluorescein on probe based confocal endomicroscopy (pCLE) with esophageal permeability (i.e. - epithelial barrier function).
研究概览
简要总结
Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
盲法说明
Investigator in the lab performing Ussing's chamber analysis will be blinded to the diagnosis of the patient
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years
- •Ability to give informed consent
排除标准
- •Esophageal varices
- •Prior esophageal or gastric surgery
- •Active gastrointestinal bleeding
- •Evidence of esophageal malignancy
- •Inability to provide informed consent
研究组 & 干预措施
Non-erosive reflux disease (NERD)
Patient's with GERD refractory to PPI with no evidence of erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.
干预措施: Confocal endomicroscopy (Procedure)
Non-erosive reflux disease (NERD)
Patient's with GERD refractory to PPI with no evidence of erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.
干预措施: Endoscopic biopsies (Diagnostic Test)
Non-erosive reflux disease (NERD)
Patient's with GERD refractory to PPI with no evidence of erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.
干预措施: Mucosal impedance (MI) (Diagnostic Test)
Barrett's esophagus/erosive esophagitis
Patient's with Barrett's esophagus or with erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.
干预措施: Confocal endomicroscopy (Procedure)
Barrett's esophagus/erosive esophagitis
Patient's with Barrett's esophagus or with erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.
干预措施: Endoscopic biopsies (Diagnostic Test)
Barrett's esophagus/erosive esophagitis
Patient's with Barrett's esophagus or with erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.
干预措施: Mucosal impedance (MI) (Diagnostic Test)
Control
Patient's with no h/o GERD or Barrett's esophagus who are undergoing endoscopy for non-GERD related indication. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.
干预措施: Confocal endomicroscopy (Procedure)
Control
Patient's with no h/o GERD or Barrett's esophagus who are undergoing endoscopy for non-GERD related indication. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.
干预措施: Endoscopic biopsies (Diagnostic Test)
Control
Patient's with no h/o GERD or Barrett's esophagus who are undergoing endoscopy for non-GERD related indication. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.
干预措施: Mucosal impedance (MI) (Diagnostic Test)
结局指标
主要结局
Correlation between the time from intravenous injection of fluorescein to visualization of fluorescein on probe based confocal endomicroscopy (pCLE) with esophageal permeability (i.e. - epithelial barrier function).
时间窗: Through study completion, an average of 1 year.
次要结局
- Compare the time from intravenous injection of fluorescein to visualization of fluorescein on probe based confocal endomicroscopy (pCLE) in patients with Barrett's esophagus and controls(Through study completion, an average of 1 year.)
- Compare the time from intravenous injection of fluorescein to visualization of fluorescein on probe based confocal endomicroscopy (pCLE) in patients with symptoms of refractory GERD and Barrett's esophagus(Through study completion, an average of 1 year.)
- Correlation between the Ussing's chamber findings (esophageal permeability) and confocal endomicroscopy findings of patients with symptoms of refractory GERD and Barrett's esophagus(Through study completion, an average of 1 year.)
- Correlation between the Ussing's chamber findings (esophageal permeability) and confocal endomicroscopy findings of patients with symptoms of refractory GERD and controls(Through study completion, an average of 1 year.)
- Correlation between the Ussing's chamber findings (esophageal permeability) and Mucosal impedance findings of patients with symptoms of refractory GERD and controls(Through study completion, an average of 1 year.)