Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic Esophagitis

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is for patients who have had a food impaction and/or difficulty swallowing, who are scheduled to have endoscopy, biopsy and possibly dilatation (stretching) of the esophagus.

Standard treatment for people who have food impaction and difficulty swallowing is endoscopy to view the esophagus, tissue biopsies of the lining of the esophagus for diagnosis, and drug therapy including steroids and drugs used to treat reflux disease. Early dilatation or stretching of the esophagus may be done at this time but not always. Some doctors prefer to wait and see if the drugs are affective.

It is not known if dilating the esophagus early in treatment adds benefit. Therefore, we are doing this study to compare the two methods of treatment. We will compare two groups: one group will have dilatation performed during the first endoscopy and one group will not have dilatation performed during endoscopy. We will see if dilatation helps prevent food impaction and improves swallowing.

Another purpose of this study is to learn more about the causes of swallowing problems, thus extra biopsies will be taken of the esophagus and store them for future research.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborator: Takeda
• Treatments: Fluticasone; Proton Pump Inhibitors

Criteria

Inclusion Criteria:

1. Male and female volunteers ≥18 years old.

2. Patients with known or suspected Eosinophilic Esophagitis.

3. Patients undergoing upper endoscopy for recent food impaction or complaint of dysphagia.

Exclusion Criteria:

1. Use of oral corticosteroids.

2. Significant medical conditions that in the investigator's judgment would compromise the subject's health and safety.

3. Contraindication to esophageal dilation based on investigator's judgment.

4. Esophageal motility abnormalities not thought to be related to Eosinophilic Esophagitis.