Clinical trial NCT00667524: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eosinophilic Esophagitis
Esophageal Stenosis
Esophageal Dilation
Esophageal Dilatation
Keywords: Eosinophilic Esophagitis
Dysphagia
Esophageal bougienage
Esophageal Dilation
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Northwestern University Feinberg School of Medicine
First posted: 2008-04-28
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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)

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.

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.

Primary outcomes:
measure: Assessment of eosinophilic esophageal infiltration before/after esophageal bougienage (without any anti-eosinophilic medication)
timeFrame: 3 months to 4 years
Secondary outcomes:
measure: Effect of dilation regarding dysphagia
timeFrame: 0 months to 4 years
measure: Duration of a positive effect
timeFrame: 0 months to 4 years
measure: Acceptance of dilation therapy by the patient
timeFrame: 0 months to 4 years after dilation therapy
measure: Intensity of post-procedural pain
timeFrame: 1 day to 30 days after dilatation therapy
measure: Duration of post-procedural pain
timeFrame: 1 day to 30 days after dilation therapy
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dpt of Gastroenterology, Bern University Hospital
Study officials:
affiliation: Dpt of Gastroenterology, Bern University Hospital, Bern
name: Alain Schoepfer, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Furuta GT, Liacouras CA, Collins MH, Gupta SK, Justinich C, Putnam PE, Bonis P, Hassall E, Straumann A, Rothenberg ME; First International Gastrointestinal Eosinophil Research Symposium (FIGERS) Subcommittees. Eosinophilic esophagitis in children and adults: a systematic review and consensus recommendations for diagnosis and treatment. Gastroenterology. 2007 Oct;133(4):1342-63. doi: 10.1053/j.gastro.2007.08.017. Epub 2007 Aug 8.
citation: Potter JW, Saeian K, Staff D, Massey BT, Komorowski RA, Shaker R, Hogan WJ. Eosinophilic esophagitis in adults: an emerging problem with unique esophageal features. Gastrointest Endosc. 2004 Mar;59(3):355-61. doi: 10.1016/s0016-5107(03)02713-5.
citation: Ngo P, Furuta GT, Antonioli DA, Fox VL. Eosinophils in the esophagus--peptic or allergic eosinophilic esophagitis? Case series of three patients with esophageal eosinophilia. Am J Gastroenterol. 2006 Jul;101(7):1666-70. doi: 10.1111/j.1572-0241.2006.00562.x.
citation: Straumann A, Spichtin HP, Grize L, Bucher KA, Beglinger C, Simon HU. Natural history of primary eosinophilic esophagitis: a follow-up of 30 adult patients for up to 11.5 years. Gastroenterology. 2003 Dec;125(6):1660-9. doi: 10.1053/j.gastro.2003.09.024.
citation: Desai TK, Stecevic V, Chang CH, Goldstein NS, Badizadegan K, Furuta GT. Association of eosinophilic inflammation with esophageal food impaction in adults. Gastrointest Endosc. 2005 Jun;61(7):795-801. doi: 10.1016/s0016-5107(05)00313-5.
citation: Baxi S, Gupta SK, Swigonski N, Fitzgerald JF. Clinical presentation of patients with eosinophilic inflammation of the esophagus. Gastrointest Endosc. 2006 Oct;64(4):473-8. doi: 10.1016/j.gie.2006.03.931. Epub 2006 Jul 26.
citation: Konikoff MR, Noel RJ, Blanchard C, Kirby C, Jameson SC, Buckmeier BK, Akers R, Cohen MB, Collins MH, Assa'ad AH, Aceves SS, Putnam PE, Rothenberg ME. A randomized, double-blind, placebo-controlled trial of fluticasone propionate for pediatric eosinophilic esophagitis. Gastroenterology. 2006 Nov;131(5):1381-91. doi: 10.1053/j.gastro.2006.08.033. Epub 2006 Aug 16.
citation: Remedios M, Campbell C, Jones DM, Kerlin P. Eosinophilic esophagitis in adults: clinical, endoscopic, histologic findings, and response to treatment with fluticasone propionate. Gastrointest Endosc. 2006 Jan;63(1):3-12. doi: 10.1016/j.gie.2005.07.049.
citation: Schoepfer AM, Gschossmann J, Scheurer U, Seibold F, Straumann A. Esophageal strictures in adult eosinophilic esophagitis: dilation is an effective and safe alternative after failure of topical corticosteroids. Endoscopy. 2008 Feb;40(2):161-4. doi: 10.1055/s-2007-995345.
citation: Schoepfer AM, Gonsalves N, Bussmann C, Conus S, Simon HU, Straumann A, Hirano I. Esophageal dilation in eosinophilic esophagitis: effectiveness, safety, and impact on the underlying inflammation. Am J Gastroenterol. 2010 May;105(5):1062-70. doi: 10.1038/ajg.2009.657. Epub 2009 Nov 24.