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

Tracking Information
First Submitted Date ICMJE	August 25, 2008
First Posted Date ICMJE	April 14, 2009
Results First Submitted Date	March 27, 2014
Results First Posted Date	May 26, 2014
Last Update Posted Date	November 6, 2017
Study Start Date ICMJE	August 2008
Actual Primary Completion Date	December 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 29, 2014)	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.; = able to swallow some solid foods; = able to swallow only semi solid foods; = able to swallow liquids only; = unable to swallow anything / total dysphagia
Original Primary Outcome Measures ICMJE; (submitted: April 13, 2009)	To determine if esophageal dilation improves symptoms of dysphagia and the incidence of food impaction in patients with Eosinophilic Esophagitis (EE). [ Time Frame: 60 days ]
Change History	Complete list of historical versions of study NCT00880906 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 13, 2009)	Immunological Assessment Into the Etiology of Eosinophilic Esophagitis [ Time Frame: 60 days ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic Esophagitis
Official Title ICMJE	Prospective, Single-Blinded, Randomized Controlled Trial With Sham Comparing Standard Therapy With or Without Esophageal Dilatation in Patients With Eosinophilic Esophagitis
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Condition ICMJE	Suspected Eosinophilic Esophagitis
Intervention ICMJE	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
Study Arms	Active Comparator: A Group A receives steroids and PPI, (SOC) and esophageal dilation. Interventions: Procedure: Esophageal dilation Drug: Steroid and Proton Pump Inhibitor Therapy; Sham Comparator: B Receives steroids and PPI only- Does not have esophageal dilation. Intervention: Drug: Steroid and Proton Pump Inhibitor Therapy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: April 13, 2009)	50
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	December 2013
Actual Primary Completion Date	December 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Male and female volunteers ≥18 years old.; Patients with known or suspected Eosinophilic Esophagitis.; Patients undergoing upper endoscopy for recent food impaction or complaint of dysphagia. Exclusion Criteria: Use of oral corticosteroids.; Significant medical conditions that in the investigator's judgment would compromise the subject's health and safety.; Contraindication to esophageal dilation based on investigator's judgment.; Esophageal motility abnormalities not thought to be related to Eosinophilic Esophagitis.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00880906
Other Study ID Numbers ICMJE	080741
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Michael Vaezi, Vanderbilt University
Study Sponsor ICMJE	Vanderbilt University
Collaborators ICMJE	Takeda
Investigators ICMJE	Principal Investigator: Michael F Vaezi, MD,PhD, MS epi vanderbilt Universtiy Medical Center
PRS Account	Vanderbilt University Medical Center
Verification Date	October 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP