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Confocal Laser Endomicroscopy in Patients With Eosinophilic Esophagitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by University of Erlangen-Nürnberg Medical School.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Helmut Neumann, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01234376
First received: November 2, 2010
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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 Intervention
Eosinophilic Esophagitis.
Device: Confocal laser endomicroscopy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Confocal Laser Endomicroscopy in Patients With Eosinophilic Esophagitis

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Effectiveness of endomicroscopy for the in vivo diagnosis of eosinophilic esophagitis [ Time Frame: November 2010 - November 2012 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Differentiation of mucosal alterations in patients with eosinophilic esophagitis compared to patients with gastroesophageal reflux disease. [ Time Frame: November 2010 - November 2012 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Control patients Device: Confocal laser endomicroscopy
Confocal laser endomicroscopy
Patients with eosinophilic esophagitis Device: Confocal laser endomicroscopy
Confocal laser endomicroscopy

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234376

Locations
Germany
University of Erlangen-Nuremberg
Erlangen, Bayern, Germany, 91054
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 
Study First Received: November 2, 2010
Last Updated: January 23, 2013
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on December 02, 2016