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增进对巴雷特食管病理生理学和治疗的理解，并为申请人提供流行病学和结果研究方面的进一步正式培训。申请人 Shaheen 博士是北卡罗来纳大学的助理教授，也是食管疾病中心的联合主任。他的导师 Robert Sandler 博士是一位著名的胃肠道流行病学家，也是胃肠生物学和疾病中心 (CGIBD) 的主任。他们提出结合教学和临床研究经验，利用北卡罗来纳大学公共卫生学院、胃肠道部门和 CGI​​BD 的资源来培养 Shaheen 博士对结果研究表现出的兴趣。杜克大学的 Dawn Provenzale 博士也将提供指导和指导，以及巴雷特食管这一主题领域的专业知识。作为临床培训的一部分提出的研究是巴雷特食管的病例对照研究。巴雷特食管是食管腺癌的癌前病变，食管腺癌是一种通常致命的癌症，其发病率呈流行趋势。巴雷特氏病与胃食管反流有关。由于我们无法对反流患者中巴雷特氏病的风险进行充分分层，因此当局建议所有慢性反流患者均接受内窥镜筛查巴雷特氏病。更好地对巴雷特风险进行分层将有助于更有针对性地使用筛查内窥镜检查。本研究的具体目的是：1) 评估肥胖与巴雷特病之间的关系，2) 评估幽门螺杆菌感染和巴雷特病的作用，3) 评估巴雷特病患者发育不良的预测因子，4) 评估巴雷特病患者与反流对照者相比的生活质量。该研究将招募 175 名有反流症状和巴雷特食管的病例，以及 350 名有反流症状但没有巴雷特食管且在北卡罗来纳大学接受内窥镜检查的对照者。参与者将完成电话采访，评估人口统计、健康习惯、早期感染幽门螺杆菌的风险因素以及反流症状。此外，还将对受试者进行生活质量测量、健康状况调查问卷和心理概况、修订的霍普金斯症状检查表。受试者将接受身高、体重、臀围和腰围的评估。数据分析将比较病例和对照之间的体重和脂肪分布，以及早期感染幽门螺杆菌的风险因素。将患有巴雷特氏病和不典型增生的受试者与仅患有巴雷特氏病的受试者进行比较，以评估不典型增生的危险因素。最后，通过将巴雷特氏症受试者与反流对照者进行比较，并控制反流程度，可以看出巴雷特氏症诊断对生活质量和心理压力的影响。