Epidemiologic Case-control Study of Barrett's Esophagus

巴雷特食管流行病学病例对照研究

• 批准号: 6517872
• 负责人: NICHOLAS J SHAHEEN
• 金额: $ 12.52万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-07-01 至 2006-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6517872
• 关键词: Barretts esophagus; Helicobacter; disease /disorder etiology; disease /disorder proneness /risk; endoscopy; human subject; interview; obesity; patient oriented research; quality of life; questionnaires; reflux esophagitis

The long-term objectives of this project are to advance the understanding of the pathophysiology and management of Barrett's esophagus, and to achieve further formal training in epidemiology and outcomes research for the applicant. Dr. Shaheen, the applicant, is an Assistant Professor at UNC and is Co-Director of the Center for Esophageal Diseases. His mentor, Dr. Robert Sandler, is an established GI epidemiologist, and Director of the Center for Gastrointestinal Biology and Disease (CGIBD). They propose a combined didactic and clinical research experience, utilizing the resources of the UNC School of Public Health, the GI Division and the CGIBD to foster Dr. Shaheen's demonstrated interest in outcomes research. Dr. Dawn Provenzale from Duke University will also provide instruction and mentoring, as well as expertise in the subject area, Barrett's esophagus. The study proposed as part of the clinical training is a case-control study of Barrett's esophagus. Barrett's esophagus is a pre-malignant lesion of esophageal adenocarcinoma, a usually lethal cancer whose incidence is increasing in epidemic proportions. Barrett's is associated with gastroesophageal reflux. Because we cannot adequately stratify risk for Barrett's among those with reflux, authorities recommend that all those with chronic reflux undergo endoscopic screening for Barrett's. Better stratification of Barrett's risk would allow for more targeted usage of screening endoscopy. The specific aims of this study are: 1) To evaluate the relationship between obesity and Barrett's, 2) To assess the role of H. pylori infection and Barrett's, 3) To assess the predictors for dysplasia among those with Barrett's, and, 4) To assess the quality of life of those with Barrett's compared to controls with reflux. The study will recruit 175 cases with reflux symptoms and Barrett's esophagus, and 350 controls with reflux symptoms and no Barrett's who present for endoscopy at UNC. Participants will complete a telephone interview assessing demographics, health habits, risk factors for early H. pylori acquisition, and reflux symptoms. Also, subjects will be administered a measure of quality of life, the Health Status Questionnaire, and a psychological profile, the Revised Hopkins Symptom Checklist. Subjects will undergo assessment of height, weight, hip and waist circumference. Data analysis will compare body mass and fat distribution, as well as risk factors for early H. pylori acquisition, between cases and controls. Subjects with Barrett's and dysplasia will be compared to those with Barrett's alone to assess for risk factors for dysplasia. Finally, by comparing subjects with Barrett's to controls with reflux, and controlling for severs of reflux, the impact of a Barrett's diagnosis on quality of life and psychological stress may be seen.

该项目的长期目标是促进对巴雷特食管的病理生理学和管理的理解，并为申请人进行进一步的流行病学和成果研究的正式培训。申请人Shaheen博士是UNC的助理教授，是食管疾病中心的联合主任。他的导师罗伯特·桑德勒（Robert Sandler）博士是一位已建立的GI流行病学家，胃肠道生物学与疾病中心主任（CGIBD）。他们提出了一项结合的教学和临床研究经验，利用UNC公共卫生学院，GI部和CGIBD的资源来培养Shaheen博士对成果研究的兴趣。杜克大学的Dawn Provenzale博士还将提供指导和指导，并在主题领域的Barrett食管方面提供专业知识。作为临床培训的一部分，该研究提出的是对巴雷特食管的病例对照研究。巴雷特的食管是食管腺癌的恶性病变，这是一种通常致命的癌症，其发病率在流行比例中增加。巴雷特与胃食管反流有关。因为我们不能充分地对Barrett的风险进行反流的风险，所以当局建议所有患有慢性反流的人都对Barrett进行了内窥镜检查。更好地分层巴雷特的风险将允许更多针对性的筛查内窥镜检查。这项研究的具体目的是：1）评估肥胖与巴雷特之间的关系，2）评估幽门螺杆菌感染和巴雷特的作用，3）评估患有巴雷特患者的异常增生的预测因子，以及4）与反流对照相比，评估Barrett的人的生活质量。这项研究将招募175例反流症状和巴雷特食管的病例，以及350例反流症状的对照，没有巴雷特在UNC上进行内窥镜检查。参与者将完成评估人口统计学，健康习惯，幽门螺杆菌早期收购的危险因素和反流症状的电话访谈。此外，将对受试者进行生活质量，健康状况问卷和心理形象的措施，即修订后的霍普金斯症状清单。受试者将对身高，体重，臀部和腰围进行评估。数据分析将比较病例和对照之间的体重和脂肪分布以及幽门螺杆菌早期获取的风险因素。将Barrett和发育不良的受试者与仅Barrett的受试者进行比较，以评估发育不良的危险因素。最后，通过将受试者与Barrett的对照进行比较，并控制反流的控制，可以看到Barrett诊断对生活质量和心理压力的影响。