Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

Esophagitis Clinical Trial

Official title:

Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00256529
• Other study ID #: 14543
• Status: Completed
• Phase: N/A
• First received: November 17, 2005
• Last updated: December 12, 2014
• Start date: November 2005
• Est. completion date: February 2012

Study information

• Verified date: December 2014
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 483
• Est. completion date: February 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

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

Locations

Country	Name	City	State
United States	Department of Veterans Affairs	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the percentage of patients who present with dysphagia who have EE by histologic criteria		December 2010	No
Secondary	To assess the demographics of the EE patients with dysphagia		December 2010	No
Secondary	To measure the frequency, severity, and time course of dysphagia in patients with EE		December 2010	No
Secondary	To assess percentage of EE patients with recurrent, versus acute dysphagia		December 2010	No