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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Michael Vaezi, Professor of Medicine, Vanderbilt University
• ClinicalTrials.gov Identifier: NCT00880906
• Other Study ID Numbers: 080741
• First Posted: April 14, 2009
• 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; 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; Fluticasone; 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