Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic Esophagitis
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 11/8/2017 |
| Start Date: | August 2008 |
| End Date: | December 2013 |
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.
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
