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
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Condition or disease |
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Eosinophilic Esophagitis Esophageal Stenosis Esophageal Dilation Esophageal Dilatation |
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 |

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

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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 |
Inclusion criteria for retrospective Database analysis:
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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
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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.
- 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.

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
Switzerland | |
Dpt of Gastroenterology, Bern University Hospital | |
Bern, Switzerland, 3010 |
Principal Investigator: | Alain Schoepfer, Dr | Dpt of Gastroenterology, Bern University Hospital, Bern |
Other Publications:
Responsible Party: | Dr Alain Schoepfer, Dpt of Gastroenerology, Bern University Hospital, Bern |
ClinicalTrials.gov Identifier: | NCT00667524 |
Other Study ID Numbers: |
KEK031_08 |
First Posted: | April 28, 2008 Key Record Dates |
Last Update Posted: | December 29, 2009 |
Last Verified: | December 2009 |
Eosinophilic Esophagitis Dysphagia Esophageal bougienage Esophageal Dilation |
Eosinophilic Esophagitis Esophagitis Esophageal Stenosis Inflammation Dilatation, Pathologic Pathologic Processes Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
Gastroenteritis Pathological Conditions, Anatomical Eosinophilia Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |