Population Based Screening for Barrett's Esophagus in Olmsted County : A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome variable for this aim will be the number of subjects in each group that need to be contacted until 20 in each group agree to participate in this study.
研究概览
简要总结
To compare participation rates in screening for Barrett's Esophagus (BE) using sedated esophagogastroduodenoscopy (EGD), unsedated transnasal endoscopy and capsule endoscopy in a population based cohort. An age and gender stratified random sample of 300 patients from a previously defined (in terms of the presence or absence of symptoms of gastroesophageal reflux using a validated questionnaire) population based cohort from Olmsted County11, 12 using the Rochester Epidemiology Project (REP), who have not undergone endoscopy, will be randomized to undergo screening using capsule endoscopy OR transnasal endoscopy OR conventional sedated endoscopy. The investigators will compare participation rates in the three arms.
To identify factors associated with non-participation in population screening for BE. The investigators will compare demographic and clinical factors in participants and non-participants, to help predict non-participation using data from prior surveys (data has been collected on patient demographics, bowel and reflux symptoms, employment, education, somatization behavior, psychological profiles using the validated Gastroesophageal Reflux questionnaire [GERQ] and the Bowel Disease Questionnaire [BDQ]) which have been completed by all targeted subjects. This preliminary will allow us to identify barriers to screening and develop interventions to increase participation in future larger studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Olmsted county resident
排除标准
- •History of known BE or endoscopy within the last 5 years;
- •History of progressive dysphagia;
- •Known Zenker's diverticulum;
- •Known epiphrenic diverticulum;
- •Known or suspected intestinal obstruction;
- •Cardiac pacemakers or other implanted electro-medical devices;
- •Pregnancy;
- •Patient expected to undergo MRI examination within 7 days after ingestion of the capsule;
- •History of prior abdominal surgery of the gastrointestinal tract (other than uncomplicated appendectomy or uncomplicated cholecystectomy) within the last six months; pregnancy;
- •History of recurrent epistaxis, moved from Olmsted County or deceased;
- •Significant illnesses that might impair ability to complete questionnaires (e.g. metastatic cancer, major stroke); and
- •Any contraindication to esophageal biopsy (such as anticoagulation using warfarin or clopidogrel [Plavix]).
结局指标
主要结局
The primary outcome variable for this aim will be the number of subjects in each group that need to be contacted until 20 in each group agree to participate in this study.
时间窗: one year
次要结局
- To access variables for prediction of non-participation: age, gender, education level, employment, marital status, esophageal symptoms(one year)