Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic Esophagitis
Condition: Suspected Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional

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.
    

Intervention name(s): Esophageal dilation; Steroid and Proton Pump Inhibitor Therapy
Intervention type(s): Procedure; Drug
Intervention description(s): The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation.
Other intervention name(s): esophageal stretching; fluticasone; dexilant
Intervention MeSH terms: Fluticasone; Proton Pump Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: eosinophilic esophagitis; esophageal food impaction; dysphagia