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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00256529
Other study ID # 14543
Secondary ID
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


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
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