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

NCT ID: NCT00880906

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2013-12-31

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.

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.

Conditions

Suspected Eosinophilic Esophagitis

Keywords

eosinophilic esophagitis; esophageal food impaction; dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A

Group A receives steroids and PPI, (SOC) and esophageal dilation.

Group Type: ACTIVE_COMPARATOR

Esophageal dilation

Intervention Type: PROCEDURE

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

Steroid and Proton Pump Inhibitor Therapy

Intervention Type: DRUG

B

Receives steroids and PPI only- Does not have esophageal dilation.

Group Type: SHAM_COMPARATOR

Steroid and Proton Pump Inhibitor Therapy

Intervention Type: DRUG

Interventions

Esophageal dilation

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

Intervention Type: PROCEDURE

Steroid and Proton Pump Inhibitor Therapy

Intervention Type: DRUG

Other Intervention Names

esophageal stretching; fluticasone; dexilant

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Michael Vaezi

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael F Vaezi, MD,PhD, MS epi

Role: PRINCIPAL_INVESTIGATOR

vanderbilt Universtiy Medical Center

Locations

Vanderbilt Unversity Medical Center Department of Gastroenterology

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

080741

Identifier Type: -

Identifier Source: org_study_id