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Eosinophilic Esophagitis: Influence of Dilation on Dysphagia and Inflammation
This study is ongoing, but not recruiting participants.
Study NCT00667524   Information provided by University of Bern
First Received: April 24, 2008   Last Updated: June 25, 2008   History of Changes

April 24, 2008
June 25, 2008
February 2008
March 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00667524 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Eosinophilic Esophagitis: Influence of Dilation on Dysphagia and Inflammation
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.

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.

 
Observational
Cohort, Retrospective
  • Eosinophilic Esophagitis
  • Esophageal Stenosis
  • Esophageal Dilation
  • Esophageal Dilatation
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
40
March 2009
March 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00667524
Dr Alain Schoepfer, Dpt of Gastroenerology, Bern University Hospital, Bern
KEK031_08
University of Bern
Feinberg School of Medicine, Northwestern University
Principal Investigator: Alain Schoepfer, Dr Dpt of Gastroenterology, Bern University Hospital, Bern
University of Bern
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP