Eosinophilic Esophagitis: Influence of Dilation on Dysphagia and Inflammation

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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

Study Description

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.

Condition or disease
Eosinophilic Esophagitis Esophageal Stenosis Esophageal Dilation Esophageal Dilatation

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 Design

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Study Type :	Observational
Actual Enrollment :	207 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
Official Title:	Eosinophilic Esophagitis: Influence of Esophageal Dilation on the Underlying Inflammation and Efficacy/Safety of the Procedure
Study Start Date :	February 2008
Actual Primary Completion Date :	March 2009
Actual Study Completion Date :	March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eosinophilic Esophagitis

Genetic and Rare Diseases Information Center resources: Eosinophilic Enteropathy

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
I

Outcome Measures

Primary Outcome Measures :

Assessment of eosinophilic esophageal infiltration before/after esophageal bougienage (without any anti-eosinophilic medication) [ Time Frame: 3 months to 4 years ]

Secondary Outcome Measures :

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 ]

Biospecimen Retention: Samples Without DNA

formalin-fixed esophageal biopsies (blinded review of histology slides)

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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)

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667524

Locations

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Switzerland
Dpt of Gastroenterology, Bern University Hospital
Bern, Switzerland, 3010

Sponsors and Collaborators

University of Bern

Feinberg School of Medicine, Northwestern University

Investigators

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Principal Investigator:	Alain Schoepfer, Dr	Dpt of Gastroenterology, Bern University Hospital, Bern

More Information

Publications of Results:

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.

Other Publications:

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. Epub 2007 Aug 8. Review.

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.

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.

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.

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.

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. Epub 2006 Jul 26.

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. Epub 2006 Aug 16.

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.

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.

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Responsible Party:	Dr Alain Schoepfer, Dpt of Gastroenerology, Bern University Hospital, Bern
ClinicalTrials.gov Identifier:	NCT00667524 History of Changes
Other Study ID Numbers:	KEK031_08
First Posted:	April 28, 2008 Key Record Dates
Last Update Posted:	December 29, 2009
Last Verified:	December 2009

Keywords provided by University of Bern:


Eosinophilic Esophagitis Dysphagia Esophageal bougienage Esophageal Dilation

Additional relevant MeSH terms:

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Eosinophilic Esophagitis Inflammation Esophagitis Dilatation, Pathologic Esophageal Stenosis Pathologic Processes Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases	Gastroenteritis Pathological Conditions, Anatomical Eosinophilia Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases

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