N/A
N=50
Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic Esophagitis
Suspected Eosinophilic Esophagitis
Bottom Line
View on ClinicalTrials.gov: NCT00880906 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Percent Change From Baseline in Dysphagia Score in Patients With Eosinophilic Esophagitis (EE) — 69; 79 Percent Change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Esophageal dilation (Procedure); Steroid and Proton Pump Inhibitor Therapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Dysphagia Score in Patients With Eosinophilic Esophagitis (EE) |
69; 79 | — |
| SECONDARY Immunological Assessment Into the Etiology of Eosinophilic Esophagitis |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male and female volunteers ≥18 years old.
- Patients with known or suspected Eosinophilic Esophagitis.
- Patients undergoing upper endoscopy for recent food impaction or complaint of dysphagia.
Exclusion Criteria
- Use of oral corticosteroids.
- Significant medical conditions that in the investigator's judgment would compromise the subject's health and safety.
- Contraindication to esophageal dilation based on investigator's judgment.
- Esophageal motility abnormalities not thought to be related to Eosinophilic Esophagitis.
Data sourced from ClinicalTrials.gov (NCT00880906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.