Barrett's Esophagus in Olmsted County

NCT00943280 | Completed

• 1 other identifier: 08-003642
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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.

Outcome Measures

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.

  one year

Secondary Outcomes (1)

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

  one year

Study Arms (3)

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 Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Olmsted county residents

You may qualify if:

• Olmsted county resident

You may not qualify if:

• 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 \[Plavix\]).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 22134936 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Gastric, GE junction and esophagus tissue samples collected.

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Ganapathy A. Prasad, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: July 22, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 6, 2012

Record last verified: 2012-01

Locations

US (1)