Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic Esophagitis (NCT00880906) | Clinical Trial Compass
CompletedNot Applicable
Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic Esophagitis
United States50 participantsStarted 2008-08
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change From Baseline in Dysphagia Score in Patients With Eosinophilic Esophagitis (EE)