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OpenTrials
Completed

NCT Number: NCT00943280

Barrett's Esophagus in Olmsted County

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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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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]).

Treatment and study plan

Primary outcomes

  1. 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

  1. To access variables for prediction of non-participation: age, gender, education level, employment, marital status, esophageal symptoms

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 22, 2009
Registry last updated
Jan 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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