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Barrett's Esophagus in Olmsted County

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00943280
First received: July 20, 2009
Last updated: January 4, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition
Barrett's Esophagus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Population Based Screening for Barrett's Esophagus in Olmsted County : A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To access variables for prediction of non-participation: age, gender, education level, employment, marital status, esophageal symptoms [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Gastric, GE junction and esophagus tissue samples collected.


Enrollment: 60
Study Start Date: January 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Olmsted county residents

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;
  • 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]).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943280

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Ganapathy A. Prasad, MD Mayo Clinic
  More Information

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ganapathy A. Prasad, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00943280     History of Changes
Other Study ID Numbers: 08-003642
Study First Received: July 20, 2009
Last Updated: January 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
probability of patient participation in each of the Groups 1, 2 and 3.
Identification of factors predicting poor participation in screening for Barrett's esophagus.

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on June 17, 2013