Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia|
- To assess the percentage of patients who present with dysphagia who have EE by histologic criteria [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
- To assess the demographics of the EE patients with dysphagia [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
- To measure the frequency, severity, and time course of dysphagia in patients with EE [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
- To assess percentage of EE patients with recurrent, versus acute dysphagia [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
4 quadrant distal and proximal biopsies of the esophagus
|Study Start Date:||November 2005|
|Study Completion Date:||February 2012|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
All subjects presenting in with dysphagia will be in this cohort.
Procedure: EGD with biopsies
All subjects presenting with dysphagia will undergo an EGD with distal and proximal biopsies of the esophagus.
Other Name: Upper endoscopy
All patients presenting with dysphagia who do not already carry a previous diagnosis for their dysphagia will be asked to enroll. If patients have undergone previous work up for dysphagia such as manometry, 24-hour probe, or barium swallow they can still participate in this study. Informed consent will take place prior to enrollment. After patients present with dysphagia they will fill-out a questionnaire regarding their dysphagia symptoms. An EGD with biopsies will then be performed. Biopsies will be taken from 4 quadrants in the proximal and distal esophagus. The distal esophagus biopsies will be taken 5 cm proximal to the Z-line. Proximal biopsies will be taken anywhere proximal to 30 cm from the incisors.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256529
|United States, Utah|
|Department of Veterans Affairs|
|Salt Lake City, Utah, United States, 84148|
|Principal Investigator:||Kathryn Byrne, M.D.||University of Utah|