Barrett's Esophagus in Olmsted County

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00943280
Recruitment Status : Completed
First Posted : July 22, 2009
Last Update Posted : January 6, 2012
Information provided by:
Mayo Clinic

July 20, 2009
July 22, 2009
January 6, 2012
January 2009
January 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00943280 on Archive Site
To access variables for prediction of non-participation: age, gender, education level, employment, marital status, esophageal symptoms [ Time Frame: one year ]
Same as current
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Barrett's Esophagus in Olmsted County
Population Based Screening for Barrett's Esophagus in Olmsted County : A Pilot Study

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.

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Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Gastric, GE junction and esophagus tissue samples collected.
Non-Probability Sample
Olmsted county residents
Barrett's Esophagus
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  • 1 EGD
    Olmsted county residents with no history of Barrett's esophagus,who have previously completed GERQ questionnaire, randomized to EGD.
  • 2 Transnasal
    Olmsted county residents with no history of Barrett's esophagus,who have previously completed GERQ questionnaire, randomized to Transnasal endoscopy.
  • 3 PillCam
    Olmsted county residents with no history of Barrett's esophagus,who have previously completed GERQ questionnaire, randomized to PillCam.
Chang JY, Talley NJ, Locke GR 3rd, Katzka DA, Schleck CD, Zinsmeister AR, Dunagan KT, Wu TT, Wang KK, Prasad GA. Population screening for barrett esophagus: a prospective randomized pilot study. Mayo Clin Proc. 2011 Dec;86(12):1174-80. doi: 10.4065/mcp.2011.0396.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2010
January 2010   (Final data collection date for primary outcome measure)

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;
  • 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]).
Sexes Eligible for Study: All
20 Years to 90 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Ganapathy A. Prasad, MD, Mayo Clinic
Mayo Clinic
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Principal Investigator: Ganapathy A. Prasad, MD Mayo Clinic
Mayo Clinic
January 2012