Expanding the Clinical Applications of Functional Luminal Imaging (EndoFLIP) in Esophageal Stenoses
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Collection of Measurements of the Luminal Narrowing Using EndoFlip
研究概览
简要总结
The purpose of this study is to investigate the use of a functional luminal imaging probe to characterize benign esophageal luminal strictures before and after dilation and identify predictors of response to therapy. Patients will be evaluated during endoscopy using functional luminal imaging (EndoFLIP; Crospon Medical Devices, Galway, Ireland) to characterize the geometry of benign luminal esophageal narrowing before and after dilation.
详细描述
To date there is no effective way to objectively characterize and predict response to endoscopic dilation of luminal strictures of the GI tract. Endoscopic dilation allows effective remediation of benign esophageal and upper GI tract strictures. Stricture dilation is performed after the stricture diameter is crudely gauged by the endoscopist. Stricture characteristics are based on the severity of symptoms and appearance. A stricture may be graded as mild, moderate, severe and as to whether or not the endoscope is able to traverse the luminal narrowing. By precisely measuring the diameter and length of a stricture, the endoscopist can know exactly what type of dilation is necessary. Benign esophageal strictures may also be refractory to dilation and thus require multiple sessions, prior to achieving successful remediation. The purpose of this study is to investigate the use of a functional luminal imaging probe to characterize benign esophageal luminal strictures before and after dilation and identify predictors of response to therapy. Patients will be evaluated during endoscopy using functional luminal imaging (EndoFLIP; Crospon Medical Devices, Galway, Ireland) to characterize the geometry of benign luminal esophageal narrowing before and after dilation. The study will include patients with strictures referred for endoscopic dilation for the following indications: radiation induced strictures, peptic strictures, RFA induced strictures, EMR induced strictures, eosinophilic esophagitis, Zenkers diverticulum, and strictures related to surgical anastomoses. In patients with benign refractory esophageal strictures referred for endoluminal prostheses EndoFLIP will be used to characterize the stricture prior to stent placement.
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
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> or = to 18 years of age
- •Referred for evaluation and treatment of benign esophageal luminal narrowing
- •Clinical diagnosis of benign esophageal luminal narrowing with documentation and imaging
- •Adult patients with benign refractory esophageal strictures referred for placement of an esophageal stent are eligible for this study
- •Willing and able to give informed consent
- •No condition or comorbidity which would prevent the patient from undergoing a successful upper endoscopy
排除标准
- •< 18 years of age
- •Pregnancy
- •History of prior endoscopic dilation* (*unless referred for placement of stent)
- •Coagulopathy
- •Inability to traverse the stricture using standard techniques
- •Patients unable to provide consent
结局指标
主要结局
Collection of Measurements of the Luminal Narrowing Using EndoFlip
时间窗: 12 Months
The study is observational and a proof of concept study. Measurements of the luminal narrowing using EndoFLIP will be obtained.
次要结局
- Observation of Pre-Endoscopic Therapy EndoFLIP Measurements(12 Months)
- Observation of Post-Endoscopic Therapy EndoFLIP Measurements(12 Months)
