Status:
COMPLETED
Eosinophilic Esophagitis: Influence of Dilation on Dysphagia and Inflammation
Lead Sponsor:
University of Bern
Collaborating Sponsors:
Northwestern University Feinberg School of Medicine
Conditions:
Eosinophilic Esophagitis
Esophageal Stenosis
Eligibility:
All Genders
18-80 years
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 ...
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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT00667524
Start Date
February 1 2008
End Date
March 1 2009
Last Update
December 29 2009
Active Locations (1)
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1
Dpt of Gastroenterology, Bern University Hospital
Bern, Switzerland, 3010