Esophagitis Clinical Trial
Official title:
Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia
Verified date | December 2014 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
This is a prospective descriptive cross sectional study to determine the percentage of patients presenting with dysphagia who are found to have eosinophilic esophagitis (EoE) and to establish which presenting factors warrant esophageal biopsies. We hypothesize that a greater than expected percentage of patients who are biopsies will have histologic changes consistent with EE.
Status | Completed |
Enrollment | 483 |
Est. completion date | February 2012 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Patients aged 18-90 presenting with dysphagia or food impaction - Ability to undergo esophagogastroduodenoscopy and biopsies - No significant cardiopulmonary disease, or other contraindication to EGD Exclusion Criteria: - Contradiction to EGD and/or biopsies such as Boerhaave's syndrome, or history or bleeding disorder or elevated INR - Inability to provide informed consent - Esophageal varices |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Department of Veterans Affairs | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the percentage of patients who present with dysphagia who have EE by histologic criteria | December 2010 | No | |
Secondary | To assess the demographics of the EE patients with dysphagia | December 2010 | No | |
Secondary | To measure the frequency, severity, and time course of dysphagia in patients with EE | December 2010 | No | |
Secondary | To assess percentage of EE patients with recurrent, versus acute dysphagia | December 2010 | No |
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