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Clinical Trials/NCT00256529
NCT00256529
Completed
Not Applicable

Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

University of Utah1 site in 1 country483 target enrollmentNovember 2005
ConditionsEsophagitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophagitis
Sponsor
University of Utah
Enrollment
483
Locations
1
Primary Endpoint
To assess the percentage of patients who present with dysphagia who have EE by histologic criteria
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 2005
End Date
February 2012
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kathryn A. Peterson

MD

University of Utah

Eligibility Criteria

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

Outcomes

Primary Outcomes

To assess the percentage of patients who present with dysphagia who have EE by histologic criteria

Time Frame: December 2010

Secondary Outcomes

  • To assess the demographics of the EE patients with dysphagia(December 2010)
  • To assess percentage of EE patients with recurrent, versus acute dysphagia(December 2010)
  • To measure the frequency, severity, and time course of dysphagia in patients with EE(December 2010)

Study Sites (1)

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