Assessment of Esophageal Epithelium Integrity With Mucosal Impedance in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Number of Patients with GERD and/or Eosinophilic Esophagitis(EoE)
研究概览
简要总结
Our hypothesis is that patients with GERD and/or Eosinophilic Esophagitis (EE) have lower esophageal impedance measurements when compared to patients who do not have GERD or EE.
详细描述
The overall goal of this project is to develop and assess a novel, inexpensive, minimally invasive technology to detect mucosal damage based on mucosal conductivity changes in the pediatric population. The study is based on preliminary work between Sandhill Scientific, Inc. and our adult gastroenterology department. They have collaborated to create a novel, minimally invasive Mucosal Impedance (MI) test (proprietary technology) based on animal studies which have shown esophageal tissue exposed to acidic and weakly acidic injurious agents causes dilation of intercellular spaces and loss of tight junctions along the squamous epithelial lining of the esophagus and results in measurable decreased baseline impedance.9 Adult studies have confirmed the correlation between decreased impedance and diseased tissue, however this has not been studied in children. We hypothesize that pediatric patients with histologic damage seen in GERD and EoE will have mucosal changes resulting in decreased electrical impedance compared to those with normal histology. We propose that this technology will accurately and reliably measure the mucosal consequence of chronic esophageal exposure to injurious gastroduodenal agents or food allergens. Thus, this test would serve as a minimally invasive screening tool for GERD and EoE prior to endoscopy, and allow longitudinal monitoring of mucosal response to therapy.
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
- 1 Year 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between 1 year and 18 years of age
- •Patients who are undergoing standard of care upper endoscopy and biopsy for complaints of dyspepsia
排除标准
- •Families unable to give informed consent/assent;
- •Patients with other active comorbid conditions including cardiac disease, pulmonary disease (excluding asthma), significant motility conditions
结局指标
主要结局
Number of Patients with GERD and/or Eosinophilic Esophagitis(EoE)
时间窗: 5 minutes
Mucosal impedance will be obtained during standard of care endoscopy and results will be available immediately. For those patients who may be undergoing ph monitoring as standard of care, those data will be compared to the mucosal impedance values obtained at bedside.
Mucosal impedance values correspond with histopathologic diagnosis in patients with EoE
时间窗: 5 minutes
次要结局
未报告次要终点
研究者
Michael Vaezi
Co-Principal Investigator
Vanderbilt University Medical Center
