Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00667524
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : December 29, 2009
Sponsor:
Collaborator:
Feinberg School of Medicine, Northwestern University
Information provided by:
University of Bern

Tracking Information
First Submitted Date April 24, 2008
First Posted Date April 28, 2008
Last Update Posted Date December 29, 2009
Study Start Date February 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 25, 2008)
Assessment of eosinophilic esophageal infiltration before/after esophageal bougienage (without any anti-eosinophilic medication) [ Time Frame: 3 months to 4 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00667524 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 25, 2008)
  • Effect of dilation regarding dysphagia [ Time Frame: 0 months to 4 years ]
  • Duration of a positive effect [ Time Frame: 0 months to 4 years ]
  • Acceptance of dilation therapy by the patient [ Time Frame: 0 months to 4 years after dilation therapy ]
  • Intensity of post-procedural pain [ Time Frame: 1 day to 30 days after dilatation therapy ]
  • Duration of post-procedural pain [ Time Frame: 1 day to 30 days after dilation therapy ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Eosinophilic Esophagitis: Influence of Dilation on Dysphagia and Inflammation
Official Title Eosinophilic Esophagitis: Influence of Esophageal Dilation on the Underlying Inflammation and Efficacy/Safety of the Procedure
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.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
formalin-fixed esophageal biopsies (blinded review of histology slides)
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)
Condition
  • Eosinophilic Esophagitis
  • Esophageal Stenosis
  • Esophageal Dilation
  • Esophageal Dilatation
Intervention Not Provided
Study Groups/Cohorts I
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 24, 2009)
207
Original Estimated Enrollment
 (submitted: April 25, 2008)
40
Actual Study Completion Date March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT00667524
Other Study ID Numbers KEK031_08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr Alain Schoepfer, Dpt of Gastroenerology, Bern University Hospital, Bern
Study Sponsor University of Bern
Collaborators Feinberg School of Medicine, Northwestern University
Investigators
Principal Investigator: Alain Schoepfer, Dr Dpt of Gastroenterology, Bern University Hospital, Bern
PRS Account University of Bern
Verification Date December 2009