Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

NCT00256529 | Completed

• 1 other identifier: 14543
• Study Type: observational
• Target: 483
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophagitis

Keywords

dysphagia; eosinophilic esophagitis

Outcome Measures

Primary Outcomes (1)

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

  December 2010

Secondary Outcomes (3)

• To assess the demographics of the EE patients with dysphagia

  December 2010

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

  December 2010

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

  December 2010

Study Arms (1)

I

All subjects presenting in with dysphagia will be in this cohort.

Procedure: EGD with biopsies

Interventions

EGD with biopsies PROCEDURE

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

Also known as: Upper endoscopy

I

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Department of Veterans Affairs

Salt Lake City, Utah, 84148, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

4 quadrant distal and proximal biopsies of the esophagus

MeSH Terms

Conditions

Esophagitis; Deglutition Disorders; Eosinophilic Esophagitis

Interventions

Endoscopy, Digestive System; Biopsy; Gastroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Investigative Techniques; Endoscopy, Gastrointestinal

Study Officials

• Kathryn Byrne, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 17, 2005
• First Posted: November 21, 2005
• Study Start: November 1, 2005
• Primary Completion: July 1, 2011
• Study Completion: February 1, 2012
• Last Updated: December 15, 2014

Record last verified: 2014-12

Locations

US (1)