At a glance
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Prospective, Single-Blinded, Randomized Controlled Trial With Sham Comparing Standard Therapy With or Without Esophageal Dilatation in Patients With Eosinophilic Esophagitis
In Brief
A clinical study evaluating Esophageal dilation and Steroid and Proton Pump Inhibitor Therapy for Suspected Eosinophilic Esophagitis. Completed, enrolled 50 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation.