A NOVEL TECHNIQUE FOR SCREENING BARRETT'S ESOSPHAGUS

胃食道癌是高加索男性中增长最快的癌症，是巴雷特食道的后果。巴雷特食道是一种由胃食道反流病(烧心)引起的癌前疾病。对Barrett‘s食道的筛查只能通过内窥镜来完成，考虑到处于危险中的人群，这是昂贵和不切实际的。这项提议的目的是设计一种可被广泛的医疗保健提供者应用于筛查巴雷特食道的“光学活检”系统。该系统将由一个光学探头组成，该探头可以放入食道，而对患者的不适最小，该探头连接到将提供实时结果的光学活组织检查控制台。主要的设计问题将是构建一种小口径的探头，这种探头可以舒适地放入食道，但又可以扩展，以便为光学活检提供与食管壁的接触。第二个设计考虑将是构建一种算法，该算法将分析来自“光学活检”的光谱信号，从而区分上胃肠道的正常和异常组织。三种拟议的探头设计将在切除的猪食道和胃中进行初步评估，以评估探头的部署及其安全性。随后，将在猪模型中对探头进行评估，以评估其性能特征。将选出最好的设计进行临床测试。临床试验将涉及在已知Barrett‘s食道的患者和接受内窥镜检查以确定其他适应症的对照组中使用该探头。探头将在内窥镜检查之前通过，并将结果与内窥镜检查结果进行比较。这些算法将来自同时进行内窥镜检查的患者的光学和组织学活检，这些患者接受Barrett‘s食道的监视内窥镜检查。开发一种可由辅助医疗人员操作的巴雷特食道筛查设备，将使大规模低成本筛查成为可能，以确定食道癌的风险患者。

Gastroesophageal cancers are the most rapidly increasing cancer in Caucasian males and are a consequence of Barrett's esophagus. Barrett's esophagus is a pre-malignant condition that is produced by gastroesophageal reflux disease (heartburn). Screening for Barrett's esophagus can only be accomplished by endoscopy that is expensive and impractical given the population at risk. The purpose of this proposal is to design an "optical biopsy" system that can be applied by a wide range of health care providers to screen for Barrett's esophagus. This system will consist of an optical probe that can be placed into the esophagus with minimal discomfort to the patient that is connected to an optical biopsy console that will provide real time results. The primary design issues will be in constructing a small caliber probe that can be comfortably placed into the esophagus and yet expandable to provide contact with the esophageal wall for an optical biopsy. The second design consideration would be in constructing an algorithm that would analyze the spectroscopic signal from the "optical biopsy" which would distinguish normal and abnormal tissue in the upper gastrointestinal tract. Three proposed probe designs will be evaluated initially in the resected porcine esophagus and stomach to assess deployment of the probes and their safety. Subsequently, the probes will be assessed in the pig model to evaluate their performance characteristics. The best design will be selected for clinical testing. The clinical trials will involve the use of the probe in patients with known Barrett's esophagus and a control group undergoing endoscopy for other indications. The probe would be passed prior to endoscopy and the results compared to the endoscopic findings. The algorithms will be derived from optical and histological biopsies taken simultaneously at endoscopy from patients undergoing surveillance endoscopy for Barrett's esophagus. The development of a screening device for Barrett's esophagus that could be operated by paramedical personnel would enable large-scale low cost screening to identify patients at risk for esophageal cancer.