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Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic Esophagitis (EOE)

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00880906
First received: August 25, 2008
Last updated: April 29, 2014
Last verified: July 2013

August 25, 2008
April 29, 2014
August 2008
December 2013   (final data collection date for primary outcome measure)
Percent Change From Baseline in Dysphagia Score in Patients With Eosinophilic Esophagitis (EE) [ Time Frame: 60 days ] [ Designated as safety issue: No ]

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
To determine if esophageal dilation improves symptoms of dysphagia and the incidence of food impaction in patients with Eosinophilic Esophagitis (EE). [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00880906 on ClinicalTrials.gov Archive Site
Immunological Assessment Into the Etiology of Eosinophilic Esophagitis [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic Esophagitis
Prospective, Single-Blinded, Randomized Controlled Trial With Sham Comparing Standard Therapy With or Without Esophageal Dilatation in Patients 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Suspected Eosinophilic Esophagitis
  • 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
  • Active Comparator: A
    Group A receives steroids and PPI, (SOC) and esophageal dilation.
    Interventions:
    • Procedure: Esophageal dilation
    • Drug: Steroid and Proton Pump Inhibitor Therapy
  • Sham Comparator: B
    Receives steroids and PPI only- Does not have esophageal dilation.
    Intervention: Drug: Steroid and Proton Pump Inhibitor Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00880906
080741
No
Michael Vaezi, Vanderbilt University
Vanderbilt University
Takeda
Principal Investigator: Michael F Vaezi, MD,PhD, MS epi vanderbilt Universtiy Medical Center
Vanderbilt University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP