Improving Screening and Surveillance in Barrett's Patients

描述(申请人提供)：巴雷特食道(BE)是一种与慢性胃食道反流病(GERD)相关的化生疾病。BE很重要，因为它可以进展为食管腺癌，这是一种死亡率高、发病率迅速上升的癌症。由于发现BE伴不典型增生或早期癌症可以治愈，胃肠病学会建议每年对GERD患者进行上消化道内窥镜筛查，大约720,000美国人接受BE内窥镜筛查，导致我们的医疗系统花费近10亿美元，如果所有BE风险患者都得到筛查，这个数字将显著增加。这笔费用的近一半是由于手术过程中患者的镇静所致。内窥镜检查的另一个局限性是诊断性能差，因为最近的研究表明，这种方法对识别BE的准确率低于50%。上内窥镜的这些缺点使其成为一个很好的改进目标。在之前的资助期间，我们开发了一种名为光学频域成像(OFDI)的新技术，该技术能够在体内以非常高的速度获取深度分辨的显微图像数据。使用球囊为中心的光学导管，我们已经在大约100名患者中展示了OFDI可以在几分钟内安全地获取整个远端食道的详细三维图像，并且该技术的灵敏度可能与内窥镜相当或可能更好。由于我们的研究侧重于评估可行性和诊断潜力，我们将对外直接投资作为有意识镇静下内窥镜检查的辅助手段。在这项建议中，我们将推进球囊导管对外直接投资技术，以便它可以用于BE筛查而无需镇静。我们将通过将对外直接投资的速度提高大约10倍，并通过开发和比较两种新型球囊导管设备来完成这一任务：经鼻探头和可吞咽的系留胶囊。然后，我们将使用激光标记方法将OFDI图像与活检配准，以确定未经镇静的球囊导管OFDI用于BE诊断的敏感性和特异性。最后，我们将在300名GERD患者中进行临床研究，以验证未使用镇静剂的球囊导管对外直接投资比内窥镜检查更敏感的假设。最后，我们将开发并验证一种改进的BE筛查工具，该工具比目前的护理标准更便宜、更准确。

DESCRIPTION (provided by applicant): Barrett's esophagus (BE) is a metaplastic condition that is associated with chronic gastroesophageal reflux disease (GERD). BE is important because it can progress to esophageal adenocarcinoma, a cancer with a high mortality rate and a rapidly rising incidence. Since identification of BE with dysplasia or early cancer can lead to cure, gastroenterological societies recommend that patients with GERD be screened by upper endoscopy Annually, ~720,000 Americans are endoscopically screened for BE, resulting in nearly a $1B cost to our health care system, a number that would increase significantly if all patients at risk for BE were screened. Nearly half of this cost is a consequence of patient sedation during the procedure. Another limitation of endoscopy is poor diagnostic performance, as recent studies have shown that this procedure has an accuracy of less than 50% for identifying BE. These shortcomings of upper endoscopy make it a good target for improvement. In the prior funding period we have developed a new technology called optical frequency domain imaging (OFDI), that is capable of acquiring depth-resolved microscopic image data at very high speeds in vivo. Using a balloon-centering optical catheter, we have demonstrated in approximately 100 patients that OFDI can safely acquire detailed three- dimensional images of the entire distal esophagus in a few minutes and that the sensitivity of this technique may be equivalent to or possibly better than that of endoscopy. Since our studies have focused on assessing feasibility and diagnostic potential, we have deployed OFDI as an adjunct to endoscopy under conscious sedation. In this proposal we will advance balloon-catheter OFDI technology so that it can be used for BE screening without sedation. We will accomplish this task by increasing the speed of OFDI by approximately a factor of 10 and by developing and comparing two novel balloon-catheter devices: a transnasal probe and a tethered capsule that can be swallowed. We will then determine the sensitivity and specificity of unsedated balloon catheter OFDI for BE diagnosis using a laser marking method to register OFDI images to biopsy. Finally, we will conduct a clinical study in 300 patients with GERD to test the hypothesis that unsedated balloon-catheter OFDI is more sensitive than endoscopy. In the end, we will have developed and validated an improved screening tool for BE that is less expensive and more accurate than the current standard of care.