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Routine Screening for Eosinophilic Esophagitis in Patients Presenting With Dysphagia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by San Antonio Uniformed Services Health Education Consortium.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01028235
First Posted: December 9, 2009
Last Update Posted: December 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
San Antonio Uniformed Services Health Education Consortium
  Purpose
The purpose of this study is to identify the prevalence of pathologic eosinophilic esophagitis (EoE) in the cohort of adult patients who present for specialty care in the gastroenterology clinics with complaint of difficulty swallowing (dysphagia). From this, the investigators will make recommendations regarding routine screening for the diagnosis in this cohort. The prevalence of EoE in patients presenting for specialty care in the gastroenterology clinics with the complaint of dysphagia is great enough that the diagnosis should be routinely screened against in this cohort.

Condition
Dysphagia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Routine Screening for Eosinophilic Esophagitis in Patients Presenting With Dysphagia

Resource links provided by NLM:


Further study details as provided by San Antonio Uniformed Services Health Education Consortium:

Biospecimen Retention:   Samples Without DNA
4 endoscopic biopsies from 5 locations: duodenum, stomach, distal esophagus, mid esophagus and proximal esophagus

Estimated Enrollment: 150
Study Start Date: January 2006
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Obstructive Dysphagia
Patients who complained of dysphagia, which had an obstructive etiology for their symptoms at the time of endoscopy (ring, mass, stricture, etc)
Non-obstructive Dysphagia
Patients whose endoscopy was normal and without any obvious etiology for their symptoms noted.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients over age 18, presenting to the Gastroenterology Clinic with the complaint of dysphagia
Criteria

Inclusion Criteria:

  • age > 18
  • complaint of dysphagia

Exclusion Criteria:

  • pregnancy
  • age <18
  • on inhaled steroids within the last 30 days
  • on systemic steroids in the last 30 days
  • known diagnosis of Eosinophilic Esophagitis
  • obvious obstructive etiology found at endoscopy
  • increased risk of bleeding (on blood thinners or anti-platelet agents other than aspirin)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028235


Contacts
Contact: Jonathan M Ricker, DO 210-292-6408 jonathan.ricker@lackland.af.mil
Contact: Scott McNeaer, DO 210-916-5244 scott.mcnear@amedd.army.mil

Locations
United States, Texas
Wilford Hall Medical Center Recruiting
San Antonio, Texas, United States, 78236
Contact: Jonathan M Ricker, DO    210-292-6408    jonathan.ricker@lackland.af.mil   
Contact: Kevin J Franklin, MD    210-292-6408    kevin.franklin1@lackland.af.mil   
Principal Investigator: Jonathan M Ricker, DO         
Brooke Army Medical Center Recruiting
San Antonio, Texas, United States, 78245
Contact: Scott McNear, DO    210-916-5244    scott.mcnear@amedd.army.mil   
Contact: Hays Arnold, MD    210-916-5244    hays.arnold@amedd.army.mil   
Sub-Investigator: Scott McNear, DO         
Sponsors and Collaborators
San Antonio Uniformed Services Health Education Consortium
Investigators
Principal Investigator: Jonathan M Ricker, DO San Antonio Uniformed Services Health Education Consortium
  More Information

Responsible Party: Jonathan M. Ricker, DO Gastroenterology Fellow, SAUSHEC
ClinicalTrials.gov Identifier: NCT01028235     History of Changes
Other Study ID Numbers: FWH20060112H
First Submitted: December 8, 2009
First Posted: December 9, 2009
Last Update Posted: December 9, 2009
Last Verified: November 2009

Keywords provided by San Antonio Uniformed Services Health Education Consortium:
Eosinophilic Esophagitis

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