Skip to main content
OpenTrials
Completed

NCT Number: NCT00667524

Eosinophilic Esophagitis: Influence of Dilation on Dysphagia and Inflammation

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Assessment of eosinophilic esophageal infiltration before/after esophageal bougienage (without any anti-eosinophilic medication)

    Time frame: 3 months to 4 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Collaborators

  • Northwestern University

Registry information

Official study title

Eosinophilic Esophagitis: Influence of Esophageal Dilation on the Underlying Inflammation and Efficacy/Safety of the Procedure

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 28, 2008
Registry last updated
Dec 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.