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

NCT00880906 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-11-06

Study results available
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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.

Conditions

  • Suspected Eosinophilic Esophagitis

Interventions

PROCEDURE

Esophageal dilation

The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation.

DRUG

Steroid and Proton Pump Inhibitor Therapy

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Michael F Vaezi, MD,PhD, MS epi · vanderbilt Universtiy Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00880906 on ClinicalTrials.gov