Eosinophilic Esophagitis: Influence of Dilation on Dysphagia and Inflammation

Sponsor

University of Bern (Other)

Overall Status

Completed

CT.gov ID

NCT00667524

Collaborator

Feinberg School of Medicine, Northwestern University (Other)

207

Enrollment

Location

12.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A database analysis and review of histological slides (retrospective) and a patient questionnaire analysis (prospective) will be conducted in Bern (Switzerland) to evaluate the efficacy and safety of esophageal dilation and its effect on the underlying eosinophilic inflammation in patients with Eosinophilic Esophagitis. This trial is investigator driven.

Condition or Disease	Intervention/Treatment	Phase
Eosinophilic Esophagitis Esophageal Stenosis Esophageal Dilation Esophageal Dilatation

Detailed Description

Eosinophilic esophagitis (EE) is a chronic, increasingly recognized disease of the esophagus, clinico-pathologically characterized by a proton-pump-inhibitor resistant, dense esophageal eosinophilia in combination with esophagus-related symptoms. Patients suffer mainly from dysphagia, a feared long-term complication is the evolution of esophageal stenoses leading to food-bolus impaction that have to be removed endoscopically. Anti-inflammatory therapy with systemic or topical corticosteroids have shown to be efficacious in children as well as in adults. However, relapses occur in general soon after the cessation of this medication. In addition, several studies have demonstrated that in adults with active EE dilation is an alternative safe and efficacious therapeutic option. Surprisingly, the symptom-free period seems to be much longer after this procedure than after medical treatment. Today, the selection of these two procedures depends more on local practices than on evidence based data, because robust data are lacking. Furthermore, there are concerns regarding the risk of the dilation-procedure (possible esophageal perforations and major bleeding). Furthermore, it has not yet been assessed if dilation changes the underlying eosinophilic inflammation. If not, investigations should be performed to evaluate if long-term anti-eosinophilic therapy is able to change the natural course of the disease and reduce the stricturing complications.

Study Design

Study Type:

Observational

Actual Enrollment :

207 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Eosinophilic Esophagitis: Influence of Esophageal Dilation on the Underlying Inflammation and Efficacy/Safety of the Procedure

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
I

Outcome Measures

Primary Outcome Measures

Assessment of eosinophilic esophageal infiltration before/after esophageal bougienage (without any anti-eosinophilic medication) [3 months to 4 years]

Secondary Outcome Measures

Effect of dilation regarding dysphagia [0 months to 4 years]
Duration of a positive effect [0 months to 4 years]
Acceptance of dilation therapy by the patient [0 months to 4 years after dilation therapy]
Intensity of post-procedural pain [1 day to 30 days after dilatation therapy]
Duration of post-procedural pain [1 day to 30 days after dilation therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria for retrospective Database analysis:

Adult patients with - according to the database inclusion criteria - confirmed active EE, having

Pre-dilational upper endoscopy (EGD) including histology and
Dilation and
Post-dilational EGD/Histo

Definitions: Active EE is defined as

Symptoms of dysphagia on almost each intake of solid food when off anti-inflammatory therapy or dietary restriction;
Presence of an eosinophilic tissue infiltration with a peak cell density of >24 eosinophils per hpf x 400 on histology of esophageal biopsies.

Inclusion criteria for additional, prospective, comprehensive histologic and immunologic
Work-Up: "Comparable" time frame between baseline and post-dilational biopsy sampling

Exclusion criteria:

Therapy with anti-eosinophilic medications 12 weeks prior to pre-dilational EGD and dilation respectively and between dilation and post-dilational EGD/Histo.