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Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

This study has been completed.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00256529
First received: November 17, 2005
Last updated: August 2, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention
Esophagitis
 Procedure: EGD with biopsies

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • To assess the percentage of patients who present with dysphagia who have EE by histologic criteria [ Time Frame: December 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the demographics of the EE patients with dysphagia [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
  • To measure the frequency, severity, and time course of dysphagia in patients with EE [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
  • To assess percentage of EE patients with recurrent, versus acute dysphagia [ Time Frame: December 2010 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

4 quadrant distal and proximal biopsies of the esophagus


Enrollment: 483
Study Start Date: November 2005
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
I
All subjects presenting in with dysphagia will be in this cohort.
 Procedure: EGD with biopsies
All subjects presenting with dysphagia will undergo an EGD with distal and proximal biopsies of the esophagus.
Other Name: Upper endoscopy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients presenting with dysphagia will be eligibile for enrollment into the study.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256529

Locations
United States, Utah
Department of Veterans Affairs
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Kathryn Byrne, M.D. University of Utah
  More Information

No publications provided

Responsible Party: Kathryn Byrne, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT00256529     History of Changes
Other Study ID Numbers: 14543
Study First Received: November 17, 2005
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
dysphagia
eosinophilic esophagitis

Additional relevant MeSH terms:
Deglutition Disorders
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
 Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013