Proton Pump Inhibitor (PPI) Responsive Eosinophilic Esophagitis EoE: Gastroesophageal Reflux Disease (GERD) or Eosinophilic Esophagitis (EoE)?

NCT01865825 | Completed

• 1 other identifier: 12-009305
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators would like to determine if there are patients with PPI responsive Eosinophilic Esophagitis Infiltration that have significant loss of esophageal distensibility suggestive of esophageal fibrosis typical of classic Eosniophilic Esophagitis. If this group of patients exists, the investigators would like to determine if they have the typical endoscopic features of EoE rather than those of GERD.

Conditions

Erosive Esophagitis

Keywords

Erosive Esophagitis; Gastroesophageal reflux disease

Outcome Measures

Primary Outcomes (1)

• Abnormal esophageal distensibility in patients with PPI responsive Eosinophilic Infiltrates to patients with Eosionophilic esophagitis and Gastroesophageal Reflux Disease.

  We will evaluate endoscopic features of Gastroesophageal Reflux Disease(GERD) by reviewing endoscopic reports and images. The presence of esophageal narrowing, furrows, rings, fragility, and white spots will be noted form the endoscopic reports prior to the initiation of the Provation report system. We will review the endoscopic reports and the endoscopic photographs on those patients evaluated after the Provation report system was initiated. All images will be reviewed by one investigator unaware of the subjects clinical data and name

  1 year

Secondary Outcomes (1)

• The relationship of abnormal esophageal distensibility to other endoscopic findings of EoE (furrows, rings, fragility, stricture)

  1 year

Study Arms (1)

Esophageal barium xray

We will recruit 20 patients with GERD without dysphagia for an esophageal barium xray for esophageal diameter measurements. The 20 Gastroesophageal Reflux Disease (GERD) patients will complete the Mayo Dysphagia Questionnaire 30-day and the Eosinophilic Esophagitis Actitivy Index (EEsAI) questionnaires

Radiation: Esophageal Barium Xray

Interventions

Esophageal Barium Xray RADIATION

•Fast for 4 hours prior to the Esophagram (upper GI x-ray). You will drink a liquid that has barium or another contrast agent in it. The radiologist will use the X-ray machine to look at your upper GI tract while you drink the contrast liquid. The x-ray exam should take between 10-15 minutes. We will have patients complete the Mayo Dysphasia Questionnaire-30 day.

Also known as: GERD, Erosive Esophagitis

Esophageal barium xray

Eligibility Criteria

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

Study Population

Patients with GERD that have been currently diagnosed with erosive esophagitis at endoscopy, at Mayo Clinic Rochester, Minnesota

You may qualify if:

• Age 18 or older
• Have either mild-to-moderate Los Angeles (LA) Classification System grade B, moderately severe LA grade C, or severe LA grade D erosive reflux esophagitis
• Or patients having a clinically indicated pH/impedance monitoring on proton pump inhibitor therapy for indications of gastroesophageal reflux disease.

You may not qualify if:

• Neoplasm of the esophagus or stomach
• Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
• Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jeffrey Alexander, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: May 31, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

US (1)