Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00256529

Enrollment

483

Registered

2005-11-21

Start date

2005-11-30

Completion date

2012-02-29

Last updated

2014-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagitis

Keywords

dysphagia, eosinophilic esophagitis

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.

Interventions

PROCEDUREEGD with biopsies

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

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
To assess the demographics of the EE patients with dysphagia	December 2010
To measure the frequency, severity, and time course of dysphagia in patients with EE	December 2010
To assess percentage of EE patients with recurrent, versus acute dysphagia	December 2010

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026