Barrett's Esophagus in Olmsted County

NCT ID: NCT00943280

Last Updated: 2012-01-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-01-31

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.

Conditions

Barrett's Esophagus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1 EGD

Olmsted county residents with no history of Barrett's esophagus,who have previously completed GERQ questionnaire, randomized to EGD.

No interventions assigned to this group

2 Transnasal

Olmsted county residents with no history of Barrett's esophagus,who have previously completed GERQ questionnaire, randomized to Transnasal endoscopy.

No interventions assigned to this group

3 PillCam

Olmsted county residents with no history of Barrett's esophagus,who have previously completed GERQ questionnaire, randomized to PillCam.

No interventions assigned to this group

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;
• 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]).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

Ganapathy A. Prasad, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22134936 (View on PubMed)

Other Identifiers

08-003642

Identifier Type: -

Identifier Source: org_study_id