Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

Completed

• Conditions: Esophagitis
• Interventions: Procedure: EGD with biopsies

• Registration Number: NCT00256529
• Lead Sponsor: University of Utah

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 Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-17
• Study First Submitted QC: 2005-11-17
• Study First Posted: 2005-11-21
• Primary Completion: 2011-07
• Study Completion: 2012-02
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-12
• Last Update Posted: 2014-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 483

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
I	EGD with biopsies	All subjects presenting in with dysphagia will be in this cohort.

Primary Outcome Measures

Name	Time	Method
To assess the percentage of patients who present with dysphagia who have EE by histologic criteria	December 2010

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Veterans Affairs; 🇺🇸 Salt Lake City, Utah, United States