ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

This study is currently recruiting participants.
Verified by University of Utah, May 2008

Sponsored by: University of Utah
Information provided by: University of Utah
ClinicalTrials.gov Identifier: NCT00256529
  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 (EE) 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

MedlinePlus related topics:   Swallowing Disorders   

U.S. FDA Resources

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

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

Biospecimen Description:

4 quadrant distal and proximal biopsies of the esophagus


Estimated Enrollment:   500
Study Start Date:   November 2005
Estimated Study Completion Date:   December 2010
Estimated Primary Completion Date:   December 2010 (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.

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 Boehaave'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

Contacts
Contact: Kathryn Byrne, M.D.     801-581-7802     kathryn.byrne@hsc.utah.edu    
Contact: Kristen Thomas, BS     801-587-9854     kristen.thomas@hsc.utah.edu    

Locations
United States, Utah
Department of Veterans Affairs     Recruiting
      Salt Lake City, Utah, United States, 84148
      Contact: Mae Go, M.D.     801-584-1231     mae.go@hsc.utah.edu    
      Sub-Investigator: Mae Go, M.D.            

Sponsors and Collaborators
University of Utah

Investigators
Principal Investigator:     Kathryn Byrne, M.D.     University of Utah    
  More Information


Responsible Party:   University of Utah ( Kathryn Byrne, M.D. )
Study ID Numbers:   14543
First Received:   November 17, 2005
Last Updated:   May 5, 2008
ClinicalTrials.gov Identifier:   NCT00256529
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Utah:
dysphagia  
eosinophilic esophagitis  

Study placed in the following topic categories:
Deglutition Disorders
Esophagitis
Otorhinolaryngologic Diseases
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases
Eosinophilic enteropathy
Esophageal Diseases
Gastroenteritis
Pharyngeal Diseases

ClinicalTrials.gov processed this record on September 19, 2008




Links to all studies - primarily for crawlers