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Confocal Laser Endomicroscopy in Patients With Eosinophilic Esophagitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01234376
Recruitment Status : Unknown
Verified January 2013 by Helmut Neumann, University of Erlangen-Nürnberg Medical School.
Recruitment status was:  Recruiting
First Posted : November 4, 2010
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Confocal laser endomicroscopy enables in vivo microscopic imaging within the mucosa layer of the gut at a subcellular resolution. Various studies have addressed the potential of endomicroscopy for the in vivo diagnosis of esophageal squamous cell carcinoma, Barrett´s esophagus and esophageal adenocarcinoma. Currently, there is only one case report from our group who noted the utility of endomicroscopy for the in vivo diagnosis of eosinophilic esophagitis.

The purpose of this study is to determine whether endomicroscopy is effective for the in vivo diagnosis of eosinophilic esophagitis.


Condition or disease Intervention/treatment
Eosinophilic Esophagitis. Device: Confocal laser endomicroscopy

Study Design

Study Type : Observational
Estimated Enrollment : 45 participants
Time Perspective: Prospective
Official Title: Confocal Laser Endomicroscopy in Patients With Eosinophilic Esophagitis
Study Start Date : November 2010
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Control patients Device: Confocal laser endomicroscopy
Confocal laser endomicroscopy
Patients with eosinophilic esophagitis Device: Confocal laser endomicroscopy
Confocal laser endomicroscopy


Outcome Measures

Primary Outcome Measures :
  1. Effectiveness of endomicroscopy for the in vivo diagnosis of eosinophilic esophagitis [ Time Frame: November 2010 - November 2012 ]

Secondary Outcome Measures :
  1. Differentiation of mucosal alterations in patients with eosinophilic esophagitis compared to patients with gastroesophageal reflux disease. [ Time Frame: November 2010 - November 2012 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients with eosinophilic esophagitis who underwent EGD for the evaluation of their symptoms.

Control patients who underwent EGD because of other reasons.

Criteria

Inclusion Criteria:

  • Written informed consent
  • Age 18-85 years
  • Ability of subjects to understand character and individual consequences of clinical trial
  • Subjects undergoing EGD

Exclusion Criteria:

  • Inability to provide written informed consent
  • Severe Coagulopathy (Prothrombin time < 50% of control, Partial thromboplastin time > 50 s)
  • Impaired renal function (Creatinine > 1.2 mg/dl)
  • Pregnancy or breast feeding
  • Active gastrointestinal bleeding
  • Known allergy to fluorescein, acriflavin or cresyl violet
  • Residing in institutions (e.g. prison)
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): NCT01234376


Contacts
Contact: Markus F. Neurath, M.D., Ph.D. 4991318535204 markus.neurath@uk-erlangen.de
Contact: Helmut Neumann, M.D., Ph.D. 4991318535204 helmut.neumann@uk-erlangen.de

Locations
Germany
University of Erlangen-Nuremberg Recruiting
Erlangen, Bayern, Germany, 91054
Contact: Helmut Neumann, M.D., Ph.D.    4991318535204    helmut.neumann@uk-erlangen.de   
Principal Investigator: Helmut Neumann, M.D., Ph.D.         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Study Director: Markus F. Neurath, M.D., Ph.D. University of Erlangen-Nürnberg
Principal Investigator: Helmut Neumann, M.D., Ph.D. University of Erlangen-Nürnberg
More Information

Responsible Party: Helmut Neumann, Professor, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01234376     History of Changes
Other Study ID Numbers: HN-0003
First Posted: November 4, 2010    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases