Improving Screening and Surveillance in Barrett's Patients

描述（由申请方提供）：巴雷特食管（BE）是一种与慢性胃食管反流病（GERD）相关的化生性疾病。BE很重要，因为它可以进展为食管腺癌，这是一种死亡率高且发病率迅速上升的癌症。由于发现BE伴异型增生或早期癌症可导致治愈，胃肠病学会建议GERD患者接受上消化道内镜检查。每年约有720，000名美国人接受BE内镜检查，导致我们的医疗保健系统花费近10亿美元，如果所有有BE风险的患者都接受筛查，这一数字将显著增加。这一成本的近一半是患者在手术过程中镇静的结果。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，该程序识别BE的准确性低于50%。上消化道内镜的这些缺点使其成为一个很好的改进目标。在上一个资助期内，我们开发了一种称为光学频域成像（OFDI）的新技术，该技术能够在活体内以非常高的速度获取深度分辨的显微图像数据。通过使用以球囊为中心的光学导管，我们已经在大约100名患者身上证明，对外直接投资可以在几分钟内安全地获得整个远端食管的详细三维图像，并且这种技术的灵敏度可能与内窥镜检查相当或可能更好。由于我们的研究重点是评估可行性和诊断潜力，我们将对外直接投资作为清醒镇静下内窥镜检查的辅助手段。在这一建议中，我们将推进球囊导管对外直接投资技术，使其可以用于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约10倍，并通过开发和比较两种新型的球囊导管装置来完成这一任务：经鼻探针和可吞咽的系留胶囊。然后，我们将使用激光标记方法将OFDI图像与活检图像进行配准，以确定非镇静球囊导管OFDI诊断BE的灵敏度和特异性。最后，我们将在300例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。最终，我们将开发并验证一种改进的BE筛查工具，该工具比当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.