Eosinophilic Esophagitis: Influence of Dilation on Dysphagia and Inflammation

December 24, 2009 updated by: University of Bern

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

207

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Dpt of Gastroenterology, Bern University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Eosinophilic Esophagitis referred to gastroenterologists in whole Switzerland working in private practice and in secondary and tertiary referral centers (Departments of Gastroenterology in hospitals)

Description

Inclusion criteria for retrospective Database analysis:

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

    1. Pre-dilational upper endoscopy (EGD) including histology and
    2. Dilation and
    3. Post-dilational EGD/Histo

  • Definitions: Active EE is defined as

    1. Symptoms of dysphagia on almost each intake of solid food when off anti-inflammatory therapy or dietary restriction;
    2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
I

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of eosinophilic esophageal infiltration before/after esophageal bougienage (without any anti-eosinophilic medication)
Time Frame: 3 months to 4 years
3 months to 4 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bern

Collaborators

Northwestern University Feinberg School of Medicine

Investigators

  • Principal Investigator: Alain Schoepfer, Dr, Dpt of Gastroenterology, Bern University Hospital, Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria

April 25, 2008

First Posted (ESTIMATE)

April 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 29, 2009

Last Update Submitted That Met QC Criteria

December 24, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK031_08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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