Eosinophilic Esophagitis: Influence of Dilation on Dysphagia and Inflammation - Full Text View

Sponsors and Collaborators:	University of Bern Feinberg School of Medicine, Northwestern University
Information provided by:	University of Bern
ClinicalTrials.gov Identifier:	NCT00667524

Purpose

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
Eosinophilic Esophagitis Esophageal Stenosis Esophageal Dilation Esophageal Dilatation

MedlinePlus related topics: Esophagus Disorders Swallowing Disorders

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Eosinophilic Esophagitis: Influence of Esophageal Dilation on the Underlying Inflammation and Efficacy/Safety of the Procedure

Further study details as provided by University of Bern:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

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

Estimated Enrollment:	40
Study Start Date:	February 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
I

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667524

Locations

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

Sponsors and Collaborators

University of Bern

Feinberg School of Medicine, Northwestern University

Investigators

Principal Investigator:

Alain Schoepfer, Dr

Dpt of Gastroenterology, Bern University Hospital, Bern

More Information

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.

Responsible Party:	Dpt of Gastroenerology, Bern University Hospital, Bern ( Dr Alain Schoepfer )
Study ID Numbers:	KEK031_08
Study First Received:	April 24, 2008
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00667524
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University of Bern:

Eosinophilic Esophagitis
Dysphagia
Esophageal bougienage
Esophageal Dilation

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Dilatation, Pathologic
Esophageal disorder
Gastrointestinal Diseases
Esophageal Stenosis
Constriction, Pathologic
Eosinophilic enteropathy

Inflammation
Deglutition Disorders
Esophagitis
Digestive System Diseases
Esophageal Diseases
Gastroenteritis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009