Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

This study has been completed.

Sponsor:

Information provided by:

University of Utah

ClinicalTrials.gov Identifier:

NCT00256529

First received: November 17, 2005

Last updated: August 2, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 17, 2005

Last Updated Date

August 2, 2011

Start Date ^ICMJE

November 2005

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00256529 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

Official Title ^ICMJE

Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Biospecimen

Retention: Samples Without DNA

Description:

4 quadrant distal and proximal biopsies of the esophagus

Sampling Method

Non-Probability Sample

Study Population

All patients presenting with dysphagia will be eligibile for enrollment into the study.

Condition ^ICMJE

Esophagitis

Intervention ^ICMJE

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

Study Group/Cohort (s)

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

Intervention: Procedure: EGD with biopsies

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

483

Completion Date

July 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00256529

Other Study ID Numbers ^ICMJE

14543

Has Data Monitoring Committee

Responsible Party

Kathryn Byrne, M.D., University of Utah

Study Sponsor ^ICMJE

University of Utah

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kathryn Byrne, M.D.

University of Utah

Information Provided By

University of Utah

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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