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Completed

NCT Number: NCT00880906

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt Unversity Medical Center Department of Gastroenterology

Nashville, Tennessee, 37212, United States

About this study

Eosinophilic esophagitis (EE) is an inflammatory condition of the esophagus found in the pediatric and adult population. It is characterized by an intense eosinophilic infiltration of the surface lining of the esophagus. EE is becoming an increasingly recognized diagnosis in individuals presenting with food bolus impaction and dysphagia. A history of chronic solid food dysphagia, food impaction and young age have all been noted characteristics in those patients subsequently diagnosed with EE. Eosinophilic esophagitis can be suspected by clinical presentation but histologic confirmation is necessary for a definitive diagnosis. The finding of large numbers of eosinophils (>15 per high powered field) on biopsy specimens are needed to confirm EE. Endoscopic features such as mucosal rings, linear furrows, proximal strictures and white esophageal papules have all been described in patients with EE.

The underlying pathophysiology of EE is poorly understood but is thought to be associated with a TH2-type allergic inflammatory response. Other studies have also suggested that immune dysregulation may play a role in the underlying pathophysiology of this disorder.

The optimal treatment of EE has not been determined. There have been studies noting that swallowed fluticasone propionate (FP), an inhaled corticosteroid, has shown benefit in adult and pediatric patients with EE. Esophageal dilation has been used in patients with EE with persistent dysphagia and food impaction. No study has evaluated the improvement in dysphagia and incidence of future food bolus impaction in those patients treated with early esophageal dilation. Our aim is to determine if esophageal dilation and standard drug therapy improves symptoms of dysphagia. We also plan to obtain and store esophageal biopsy specimens for future immunologic assessment to help determine the underlying pathophysiology Eosinophilic Esophagitis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esophageal dilation

Procedure

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

Other names: esophageal stretching

Steroid and Proton Pump Inhibitor Therapy

Drug

Other names: fluticasone, dexilant

Primary outcomes

  1. Percent Change From Baseline in Dysphagia Score in Patients With Eosinophilic Esophagitis (EE)

    Time frame: 60 days

    Dysphagia Scores:

    0 = able to eat normal diet / no dysphagia.

    • = able to swallow some solid foods
    • = able to swallow only semi solid foods
    • = able to swallow liquids only
    • = unable to swallow anything / total dysphagia

Secondary outcomes

  1. Immunological Assessment Into the Etiology of Eosinophilic Esophagitis

    Time frame: 60 days

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • Takeda

Registry information

Official study title

Prospective, Single-Blinded, Randomized Controlled Trial With Sham Comparing Standard Therapy With or Without Esophageal Dilatation in Patients With Eosinophilic Esophagitis

Acronym: EOE

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Apr 14, 2009
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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