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Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

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ClinicalTrials.gov Identifier: NCT00256529
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : December 15, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Esophagitis Procedure: EGD with biopsies

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.

Study Design

Study Type : Observational
Actual Enrollment : 483 participants
Time Perspective: Prospective
Official Title: Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia
Study Start Date : November 2005
Primary Completion Date : July 2011
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. To assess the percentage of patients who present with dysphagia who have EE by histologic criteria [ Time Frame: December 2010 ]

Secondary Outcome Measures :
  1. To assess the demographics of the EE patients with dysphagia [ Time Frame: December 2010 ]
  2. To measure the frequency, severity, and time course of dysphagia in patients with EE [ Time Frame: December 2010 ]
  3. To assess percentage of EE patients with recurrent, versus acute dysphagia [ Time Frame: December 2010 ]

Biospecimen Retention:   Samples Without DNA
4 quadrant distal and proximal biopsies of the esophagus

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients presenting with dysphagia will be eligibile for enrollment into the study.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256529

United States, Utah
Department of Veterans Affairs
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
University of Utah
Principal Investigator: Kathryn Byrne, M.D. University of Utah
More Information

Responsible Party: Kathryn A. Peterson, MD, University of Utah
ClinicalTrials.gov Identifier: NCT00256529     History of Changes
Other Study ID Numbers: 14543
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: December 15, 2014
Last Verified: December 2014

Keywords provided by Kathryn A. Peterson, University of Utah:
eosinophilic esophagitis

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Leukocyte Disorders
Hematologic Diseases
Immune System Diseases
Eosinophilic Esophagitis
Hypersensitivity, Immediate