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NCT Number: NCT00256529

Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

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.

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Key information

Conditions

Esophagitis Deglutition Disorders Digestive System Diseases Eosinophilia Eosinophilic Esophagitis Esophageal Diseases Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Veterans Affairs

Salt Lake City, Utah, 84148, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EGD with biopsies

Procedure

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

Other names: Upper endoscopy

Primary outcomes

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

    Time frame: December 2010

Secondary outcomes

  1. To assess the demographics of the EE patients with dysphagia

    Time frame: December 2010

  2. To measure the frequency, severity, and time course of dysphagia in patients with EE

    Time frame: December 2010

  3. To assess percentage of EE patients with recurrent, versus acute dysphagia

    Time frame: December 2010

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2005
Primary completion
2011
Study completion
2012
First posted
Nov 21, 2005
Registry last updated
Dec 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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