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Eosinophilic EsophagitisNCT00667524

Eosinophilic Esophagitis: Influence of Dilation on Dysphagia and Inflammation

An observational study of Eosinophilic Esophagitis and Esophageal Stenosis, run by University of Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
207 participants
Where
1 siteSwitzerland
Study dates
Feb 2008to Mar 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

  • 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;
Show all 9Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Dpt of Gastroenterology, Bern University Hospital

    Bern, 3010

Other trials in Switzerland

About this study

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

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.

Read the 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.

Keywords
Eosinophilic Esophagitis, Dysphagia, Esophageal bougienage, Esophageal Dilation
Medical subject headings
Eosinophilic Esophagitis, Esophageal Stenosis, Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00667524
Study groupRoleWhat they receive
INot described

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 months to 4 years

Secondary outcomes (5)

  1. Effect of dilation regarding dysphagia

    Measured: 0 months to 4 years

  2. Duration of a positive effect

    Measured: 0 months to 4 years

  3. Acceptance of dilation therapy by the patient

    Measured: 0 months to 4 years after dilation therapy

  4. Intensity of post-procedural pain

    Measured: 1 day to 30 days after dilatation therapy

  5. Duration of post-procedural pain

    Measured: 1 day to 30 days after dilation therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionMar 2009
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00667524
Sponsor's protocol ID
KEK031_08
Status last verified
Dec 2009
First submitted
24 Apr 2008
Last updated
29 Dec 2009
Results posted
No
Data monitoring committee
No

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. doi: 10.1053/j.gastro.2007.08.017. Epub 2007 Aug 8.

    PubMed 17919504

  • 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.

    PubMed 14997131

  • 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.

    PubMed 16863575

  • 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.

    PubMed 14724818

  • 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.

    PubMed 15933677

  • 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.

    PubMed 16996334

  • 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.

    PubMed 17101314

  • 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.

    PubMed 16377308

  • 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.

    PubMed 18253909

  • 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.

    PubMed 19935783

Questions about this trial

What is this clinical trial studying?

An observational study of Eosinophilic Esophagitis and Esophageal Stenosis, run by University of Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of eosinophilic esophageal infiltration before/after esophageal bougienage (without any anti-eosinophilic medication) (time frame: 3 months to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00667524, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2009.

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