Skip to main content
Clinical Trials/NCT00943280
NCT00943280
Completed
Not Applicable

Population Based Screening for Barrett's Esophagus in Olmsted County : A Pilot Study

Mayo Clinic1 site in 1 country60 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Barrett's Esophagus
Sponsor
Mayo Clinic
Enrollment
60
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
January 2010
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Olmsted county resident

Exclusion Criteria

  • 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;

Outcomes

Primary Outcomes

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.

Time Frame: one year

Secondary Outcomes

  • To access variables for prediction of non-participation: age, gender, education level, employment, marital status, esophageal symptoms(one year)

Study Sites (1)

Loading locations...

Similar Trials