Diagnosis of Acid Reflux Disease Using Novel Imaging: A Prospective Study

描述(由申请人提供)： 项目摘要：胃食道反流病(GERD)是一种在退伍军人中常见的慢性疾病，与每年超过100亿美元的药品费用有关。只有30-40%有反流症状的患者有糜烂性食管炎。绝大多数人患有NERD；这种情况下，标准的内窥镜检查无法发现任何粘膜断裂，也无法确认诊断。不幸的是，诊断书呆子的黄金标准并不存在。NERD患者的24小时食道pH监测和组织学食道粘膜变化的准确性有限，无法在临床上常规使用。窄带成像(NBI)使用光谱窄带滤光片(集成到标准内窥镜中)，并能够成像乳头内毛细血管环(IPCL)等特征；这些特征在标准内窥镜检查中无法识别。初步结果表明，NBI内窥镜在诊断NERD方面可能比标准内窥镜有显著进步。我们的假设是，NBI可以识别远端食道的变化，这些变化对诊断NERD患者具有特异性。具体目标#1：比较NERD患者(病例)和对照组食道远端的NBI特征。具体目标2：确定NERD患者的NBI特征在PPI治疗后是否消失。具体目标#3：将NBI发现与食道组织学相关联。具体目标#4：评估观察者内部和观察者之间对提出的诊断NERD标准的认可程度。病例将被定义为有反流症状的患者(通过两份有效的问卷进行评估)，没有肉眼可见的侵蚀和异常的食道pH结果(NERD组)。对照受试者将包括无反流症状、无肉眼糜烂和食道PH值正常的患者。为了确定NBI结果作为疗效的预测因子，将使用有效的GERD问卷评估随机进入PPI组的病例的治疗反应，并将其与IPCL编号和微侵蚀的存在相关联。此外，有反流症状、无肉眼糜烂和食道pH值正常的患者的NBI结果也将与对照组进行比较。将从远端食道获得两个活组织检查，以及数字图像和视频记录。统计分析如下：Aim 1卡方检验和t检验；运用Logistic回归和优势比计算，Aim 2-McNemar检验和Kappa统计，Aim 3-Spearman‘s相关系数和Aim 4-组内相关系数。对退伍军人医疗保健的潜在影响：GERD在退伍军人中很常见，通过消除额外检查的需要和降低不必要的药品成本，NBI内窥镜检查可能会对患有NERD的退伍军人产生相当大的积极影响。 公共卫生相关性： 项目简介：胃酸反流病在退伍军人中很常见，与每年超过100亿美元的药品成本有关。通过消除额外检查的需要和降低不必要的药物成本，窄带成像(NBI)内窥镜可以对患有胃酸反流的退伍军人产生相当大的积极影响。

DESCRIPTION (provided by applicant): Project Summary: Gastroesophageal reflux disease (GERD), a common chronic disorder in the veteran population, is associated with drug costs exceeding $ 10 billion/year. Only 30-40% of patients with reflux symptoms have erosive esophagitis. The vast majority suffers from NERD; a condition in which standard endoscopy fails to identify any mucosal breaks and is unable to confirm the diagnosis. Unfortunately, a gold standard for the diagnosis of NERD does not exist. 24-hour esophageal pH monitoring and histologic esophageal mucosal changes in NERD patients have limited accuracy to be routinely used in clinical practice. Narrow band imaging (NBI) utilizes spectral narrow band filters (incorporated into standard endoscopes) and enables imaging of features such as intrapapillary capillary loops (IPCLs); features not identified during standard endoscopy. Preliminary results have shown that NBI endoscopy may represent a significant improvement over standard endoscopy for the diagnosis of NERD. Our hypothesis is that NBI identifies changes in the distal esophagus that are specific for diagnosing patients with NERD. Specific Aim #1: To compare NBI features in the distal esophagus in patients with NERD (cases) and controls. Specific Aim #2: To determine whether the NBI features in NERD patients resolve after PPI therapy. Specific Aim #3: To correlate NBI findings with esophageal histology. Specific Aim #4: To assess the intra- and interobserver agreement for recognition of the proposed criteria for diagnosing NERD. Cases will be defined as patients with reflux symptoms (assessed by two validated questionnaires) with absent macroscopic erosions and abnormal esophageal pH results (NERD group). Control subjects will include patients with no reflux symptoms, absent macroscopic erosions and a normal esophageal pH result. To identify NBI findings as predictors of response, response to therapy in cases randomized to the PPI arm will be assessed using a validated GERD questionnaire and correlated with IPCL number and presence of microerosion. In addition, NBI findings in patients with reflux symptoms, no macroscopic erosions and normal esophageal pH result will also be compared with controls. Two biopsies will be obtained from the distal esophagus along with digital images and video- recordings. Statistical analysis will be done as follows: Aim 1 - chi-square and t-test; with logistic regression and calculation of odds ratios, Aim 2- McNemar's test and kappa statistic, Aim 3- Spearman's correlation coefficient and Aim 4- intraclass correlation coefficient. Potential impact on Veterans Health Care: GERD is common among veterans and by obviating the need for additional investigations and reducing unnecessary drug costs, NBI endoscopy could have a considerable positive impact on veterans with NERD. PUBLIC HEALTH RELEVANCE: Project Narrative: Acid reflux disease is common among veterans and associated with drug costs exceeding $ 10 billion/year. By obviating the need for additional investigations and reducing unnecessary drug costs, Narrow Band Imaging (NBI) endoscopy could have a considerable positive impact on veterans with acid reflux.