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

描述（由申请人提供）： 项目摘要：胃食管反流病（GERD）是退伍军人群体中常见的慢性疾病，与超过100亿美元/年的药物费用相关。只有30-40%有反流症状的患者有糜烂性食管炎。绝大多数患者患有NERD;标准内窥镜检查无法识别任何粘膜破损，无法确诊。不幸的是，NERD诊断的金标准并不存在。24-NERD患者的食管pH值监测和食管粘膜组织学变化在临床实践中常规使用的准确性有限。窄带成像（NBI）利用光谱窄带滤波器（集成到标准内窥镜中），并能够对乳头内毛细血管袢（IPCL）等特征进行成像;这些特征在标准内窥镜检查期间无法识别。初步结果表明，NBI内镜可能代表了诊断NERD的标准内镜的显着改善。我们的假设是，NBI确定了食管远端的变化，特异性诊断NERD患者。具体目标#1：比较NERD患者（病例）和对照组食管远端的NBI特征。具体目标#2：确定NERD患者的NBI特征是否在PPI治疗后消退。具体目标#3：将NBI结果与食管组织学相关联。具体目标#4：评估观察者内和观察者间对诊断NERD的拟议标准的认可。病例将定义为有反流症状（通过两份经验证的问卷评估）且无肉眼糜烂和食管pH值异常结果的患者（NERD组）。对照受试者将包括无反流症状、无肉眼可见糜烂和食管pH值正常的患者。为了将NBI结果确定为缓解预测因子，将使用经验证的GERD问卷评估随机分配至PPI组的病例的治疗缓解，并将其与IPCL数量和微糜烂的存在相关联。此外，还将有反流症状、无肉眼糜烂和食管pH值正常的患者的NBI结果与对照组进行比较。将从远端食管沿着获得两个活检组织，并提供数字图像和视频记录。统计分析如下：Aim 1 -卡方和t检验; logistic回归和比值比计算，Aim 2- McNemar检验和kappa统计，Aim 3-斯皮尔曼相关系数和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，通过避免额外的调查和减少不必要的药物费用，NBI内窥镜检查可能对NERD退伍军人产生相当大的积极影响。 公共卫生相关性： 项目叙述：胃酸反流病在退伍军人中很常见，与超过100亿美元/年的药物费用有关。通过避免需要额外的调查和减少不必要的药物费用，窄带成像（NBI）内窥镜可以有相当大的积极影响退伍军人与酸反流。

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.