Barrett's Esophagus in Olmsted County

Barrett's Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943280
• Other study ID #: 08-003642
• Status: Completed
• Phase: N/A
• First received: July 20, 2009
• Last updated: January 4, 2012
• Start date: January 2009
• Est. completion date: January 2010

Study information

• Verified date: January 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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]).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To access variables for prediction of non-participation: age, gender, education level, employment, marital status, esophageal symptoms		one year	No