Clinical trial NCT00943280: Barrett's Esophagus in Olmsted County
Official title: Population Based Screening for Barrett's Esophagus in Olmsted County : A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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.
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-07-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Olmsted county residents

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.


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 \[Plavix\]).

Primary outcomes:
measure: 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.
timeFrame: one year
Secondary outcomes:
measure: To access variables for prediction of non-participation: age, gender, education level, employment, marital status, esophageal symptoms
timeFrame: one year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ganapathy A. Prasad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.