Eosinophilic Esophagitis: Influence of Dilation on Dysphagia and Inflammation

This study has been completed.
Sponsor:
Collaborator:
Feinberg School of Medicine, Northwestern University
Information provided by:
University of Bern
ClinicalTrials.gov Identifier:
NCT00667524
First received: April 24, 2008
Last updated: December 24, 2009
Last verified: December 2009
  Purpose

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
Eosinophilic Esophagitis
Esophageal Stenosis
Esophageal Dilation
Esophageal Dilatation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Eosinophilic Esophagitis: Influence of Esophageal Dilation on the Underlying Inflammation and Efficacy/Safety of the Procedure

Resource links provided by NLM:


Further study details as provided by University of Bern:

Primary Outcome Measures:
  • Assessment of eosinophilic esophageal infiltration before/after esophageal bougienage (without any anti-eosinophilic medication) [ Time Frame: 3 months to 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effect of dilation regarding dysphagia [ Time Frame: 0 months to 4 years ] [ Designated as safety issue: No ]
  • Duration of a positive effect [ Time Frame: 0 months to 4 years ] [ Designated as safety issue: No ]
  • Acceptance of dilation therapy by the patient [ Time Frame: 0 months to 4 years after dilation therapy ] [ Designated as safety issue: No ]
  • Intensity of post-procedural pain [ Time Frame: 1 day to 30 days after dilatation therapy ] [ Designated as safety issue: No ]
  • Duration of post-procedural pain [ Time Frame: 1 day to 30 days after dilation therapy ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

formalin-fixed esophageal biopsies (blinded review of histology slides)


Enrollment: 207
Study Start Date: February 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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)

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667524

Locations
Switzerland
Dpt of Gastroenterology, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University of Bern
Feinberg School of Medicine, Northwestern University
Investigators
Principal Investigator: Alain Schoepfer, Dr Dpt of Gastroenterology, Bern University Hospital, Bern
  More Information

Publications:

Responsible Party: Dr Alain Schoepfer, Dpt of Gastroenerology, Bern University Hospital, Bern
ClinicalTrials.gov Identifier: NCT00667524     History of Changes
Other Study ID Numbers: KEK031_08
Study First Received: April 24, 2008
Last Updated: December 24, 2009
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Bern:
Eosinophilic Esophagitis
Dysphagia
Esophageal bougienage
Esophageal Dilation

Additional relevant MeSH terms:
Dilatation, Pathologic
Esophageal Stenosis
Esophagitis
Inflammation
Eosinophilic Esophagitis
Pathological Conditions, Anatomical
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Pathologic Processes
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014