NCT00667524

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

December 29, 2009

Status Verified

December 1, 2009

Enrollment Period

1.1 years

First QC Date

April 24, 2008

Last Update Submit

December 24, 2009

Conditions

Eosinophilic EsophagitisEsophageal StenosisEsophageal DilationEsophageal Dilatation

Keywords

Eosinophilic EsophagitisDysphagiaEsophageal bougienageEsophageal Dilation

Outcome Measures

Primary Outcomes (1)

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

    3 months to 4 years

Secondary Outcomes (5)

  • Effect of dilation regarding dysphagia

    0 months to 4 years

  • Duration of a positive effect

    0 months to 4 years

  • Acceptance of dilation therapy by the patient

    0 months to 4 years after dilation therapy

  • Intensity of post-procedural pain

    1 day to 30 days after dilatation therapy

  • Duration of post-procedural pain

    1 day to 30 days after dilation therapy

Study Arms (1)

I

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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.
  • Work-Up: "Comparable" time frame between baseline and post-dilational biopsy sampling

You may not qualify if:

  • Therapy with anti-eosinophilic medications 12 weeks prior to pre-dilational EGD and dilation respectively and between dilation and post-dilational EGD/Histo.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dpt of Gastroenterology, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (10)

  • 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.

    PMID: 17919504BACKGROUND

  • 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.

    PMID: 14997131BACKGROUND

  • 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.

    PMID: 16863575BACKGROUND

  • 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.

    PMID: 14724818BACKGROUND

  • 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.

    PMID: 15933677BACKGROUND

  • 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.

    PMID: 16996334BACKGROUND

  • 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.

    PMID: 17101314BACKGROUND

  • 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.

    PMID: 16377308BACKGROUND

  • 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.

    PMID: 18253909BACKGROUND

  • 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.

    PMID: 19935783RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Eosinophilic EsophagitisEsophageal StenosisDeglutition Disorders

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Alain Schoepfer, Dr

    Dpt of Gastroenterology, Bern University Hospital, Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 24, 2008

First Posted

April 28, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

December 29, 2009

Record last verified: 2009-12

Locations

CH(1)