Suspected Eosinophilic Esophagitis
Conditions
Keywords
eosinophilic esophagitis, esophageal food impaction, dysphagia
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.
Interventions
PROCEDUREEsophageal dilation
The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation.
DRUGSteroid and Proton Pump Inhibitor Therapy
Sponsors
Takeda
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Dysphagia Score in Patients With Eosinophilic Esophagitis (EE) | 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
| Measure | Time frame |
|---|---|
| Immunological Assessment Into the Etiology of Eosinophilic Esophagitis | 60 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A Receives Routine Care and Esophageal Dilatation Group A receives steroids and PPI, (SOC) and esophageal dilation.
Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation. | 29 |
| Group B Receives SOC Only Receives steroids and PPI only- Does not have esophageal dilation. | 21 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not meet criteria following patholog | 12 | 6 |
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Group A Receives Routine Care and Esophageal Dilatation | Group B Receives SOC Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 20 Participants | 49 Participants |
| Age, Continuous | 35 Years | 32 Years | 33 Years |
| Region of Enrollment United States | 29 participants | 21 participants | 50 participants |
| Sex: Female, Male Female | 13 Participants | 9 Participants | 22 Participants |
| Sex: Female, Male Male | 16 Participants | 12 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 14 |
| serious Total, serious adverse events | 0 / 17 | 0 / 14 |
Outcome results
Primary
Percent Change From Baseline in Dysphagia Score in Patients With Eosinophilic Esophagitis (EE)
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
Time frame: 60 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A Receives Routine Care and Esophageal Dilatation | Percent Change From Baseline in Dysphagia Score in Patients With Eosinophilic Esophagitis (EE) | 69 Percent Change |
| Group B Receives SOC Only | Percent Change From Baseline in Dysphagia Score in Patients With Eosinophilic Esophagitis (EE) | 79 Percent Change |
Secondary
Immunological Assessment Into the Etiology of Eosinophilic Esophagitis
Time frame: 60 days
Population: Saved samples were not analyzed due to there being no difference in the primary outcome measure.