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
  Purpose

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 Intervention
Suspected Eosinophilic Esophagitis
Procedure: Esophageal dilation
Drug: Steroid and Proton Pump Inhibitor Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Immunological Assessment Into the Etiology of Eosinophilic Esophagitis [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: August 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880906

Locations
United States, Tennessee
Vanderbilt Unversity Medical Center Department of Gastroenterology
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Takeda
Investigators
Principal Investigator: Michael F Vaezi, MD,PhD, MS epi vanderbilt Universtiy Medical Center
  More Information

No publications provided

Responsible Party: Michael Vaezi, Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00880906     History of Changes
Other Study ID Numbers: 080741
Study First Received: August 25, 2008
Results First Received: March 27, 2014
Last Updated: April 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
eosinophilic esophagitis
esophageal food impaction
dysphagia

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014