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Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

NCT ID: NCT00256529

Last Updated: 2014-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

483 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-11-30

Study Completion Date

2012-02-29

Brief Summary

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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

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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.

Conditions

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Esophagitis

Keywords

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dysphagia eosinophilic esophagitis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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I

All subjects presenting in with dysphagia will be in this cohort.

EGD with biopsies

Intervention Type PROCEDURE

All subjects presenting with dysphagia will undergo an EGD with distal and proximal biopsies of the esophagus.

Interventions

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EGD with biopsies

All subjects presenting with dysphagia will undergo an EGD with distal and proximal biopsies of the esophagus.

Intervention Type PROCEDURE

Other Intervention Names

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Upper endoscopy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Kathryn A. Peterson

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kathryn Byrne, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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Department of Veterans Affairs

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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14543

Identifier Type: -

Identifier Source: org_study_id