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Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

This study has been completed.
Information provided by (Responsible Party):
Kathryn A. Peterson, University of Utah Identifier:
First received: November 17, 2005
Last updated: December 12, 2014
Last verified: December 2014
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 Intervention
Procedure: EGD with biopsies

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

Resource links provided by NLM:

Further study details as provided by Kathryn A. Peterson, University of Utah:

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

Secondary Outcome Measures:
  • To assess the demographics of the EE patients with dysphagia [ Time Frame: December 2010 ]
  • To measure the frequency, severity, and time course of dysphagia in patients with EE [ Time Frame: December 2010 ]
  • 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

Enrollment: 483
Study Start Date: November 2005
Study Completion Date: February 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

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
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Please refer to this study by its identifier: 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 Identifier: NCT00256529     History of Changes
Other Study ID Numbers: 14543
Study First Received: November 17, 2005
Last Updated: December 12, 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
Hypersensitivity processed this record on May 25, 2017