Eosinophilic Esophagitis: Influence of Dilation on Dysphagia and Inflammation

Completed

• Conditions: Eosinophilic Esophagitis; Esophageal Stenosis; Esophageal Dilation; Esophageal Dilatation

• Registration Number: NCT00667524
• Lead Sponsor: University of Bern

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.

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 Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-04-24
• Study First Submitted QC: 2008-04-25
• Study First Posted: 2008-04-28
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-24
• Last Update Posted: 2009-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Effect of dilation regarding dysphagia	0 months to 4 years
Duration of a positive effect	0 months to 4 years
Duration of post-procedural pain	1 day to 30 days after dilation therapy
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

Trial Locations

Locations (1)

Dpt of Gastroenterology, Bern University Hospital; 🇨🇭 Bern, Switzerland