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Eosinophilic Esophagitis: Influence of Dilation on Dysphagia and Inflammation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00667524
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : December 29, 2009
Feinberg School of Medicine, Northwestern University
Information provided by:
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.

Condition or disease
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.

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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 : February 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Primary Outcome Measures :
  1. Assessment of eosinophilic esophageal infiltration before/after esophageal bougienage (without any anti-eosinophilic medication) [ Time Frame: 3 months to 4 years ]

Secondary Outcome Measures :
  1. Effect of dilation regarding dysphagia [ Time Frame: 0 months to 4 years ]
  2. Duration of a positive effect [ Time Frame: 0 months to 4 years ]
  3. Acceptance of dilation therapy by the patient [ Time Frame: 0 months to 4 years after dilation therapy ]
  4. Intensity of post-procedural pain [ Time Frame: 1 day to 30 days after dilatation therapy ]
  5. Duration of post-procedural pain [ Time Frame: 1 day to 30 days after dilation therapy ]

Biospecimen Retention:   Samples Without DNA
formalin-fixed esophageal biopsies (blinded review of histology slides)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00667524

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Dpt of Gastroenterology, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University of Bern
Feinberg School of Medicine, Northwestern University
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Principal Investigator: Alain Schoepfer, Dr Dpt of Gastroenterology, Bern University Hospital, Bern
Publications of Results:
Other Publications:

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Responsible Party: Dr Alain Schoepfer, Dpt of Gastroenerology, Bern University Hospital, Bern Identifier: NCT00667524    
Other Study ID Numbers: KEK031_08
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: December 29, 2009
Last Verified: December 2009
Keywords provided by University of Bern:
Eosinophilic Esophagitis
Esophageal bougienage
Esophageal Dilation
Additional relevant MeSH terms:
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Eosinophilic Esophagitis
Esophageal Stenosis
Dilatation, Pathologic
Pathologic Processes
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Immune System Diseases