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Trial record 1 of 1 for:    Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic Esophagitis (EOE)
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Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic Esophagitis (EOE)

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ClinicalTrials.gov Identifier: NCT00880906
Recruitment Status : Completed
First Posted : April 14, 2009
Results First Posted : May 26, 2014
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University

Brief 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.

Condition or disease Intervention/treatment Phase
Suspected Eosinophilic Esophagitis Procedure: Esophageal dilation Drug: Steroid and Proton Pump Inhibitor Therapy Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective, Single-Blinded, Randomized Controlled Trial With Sham Comparing Standard Therapy With or Without Esophageal Dilatation in Patients With Eosinophilic Esophagitis
Study Start Date : August 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Active Comparator: A
Group A receives steroids and PPI, (SOC) and esophageal dilation.
Procedure: Esophageal dilation
The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation.
Other Name: esophageal stretching

Drug: Steroid and Proton Pump Inhibitor Therapy
Other Names:
  • fluticasone
  • dexilant

Sham Comparator: B
Receives steroids and PPI only- Does not have esophageal dilation.
Drug: Steroid and Proton Pump Inhibitor Therapy
Other Names:
  • fluticasone
  • dexilant

Primary Outcome Measures :
  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.

    1. = able to swallow some solid foods
    2. = able to swallow only semi solid foods
    3. = able to swallow liquids only
    4. = unable to swallow anything / total dysphagia

Secondary Outcome Measures :
  1. Immunological Assessment Into the Etiology of Eosinophilic Esophagitis [ Time Frame: 60 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male and female volunteers ≥18 years old.
  2. Patients with known or suspected Eosinophilic Esophagitis.
  3. Patients undergoing upper endoscopy for recent food impaction or complaint of dysphagia.

Exclusion Criteria:

  1. Use of oral corticosteroids.
  2. Significant medical conditions that in the investigator's judgment would compromise the subject's health and safety.
  3. Contraindication to esophageal dilation based on investigator's judgment.
  4. Esophageal motility abnormalities not thought to be related to Eosinophilic Esophagitis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880906

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United States, Tennessee
Vanderbilt Unversity Medical Center Department of Gastroenterology
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
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Principal Investigator: Michael F Vaezi, MD,PhD, MS epi vanderbilt Universtiy Medical Center
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Responsible Party: Michael Vaezi, Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00880906    
Other Study ID Numbers: 080741
First Posted: April 14, 2009    Key Record Dates
Results First Posted: May 26, 2014
Last Update Posted: November 6, 2017
Last Verified: October 2017
Keywords provided by Michael Vaezi, Vanderbilt University:
eosinophilic esophagitis
esophageal food impaction
Additional relevant MeSH terms:
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Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Immune System Diseases
Proton Pump Inhibitors
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action