Confocal Laser Endomicroscopy in Patients With Eosinophilic Esophagitis

NCT01234376 | Completed

• 1 other identifier: HN-0003
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

• Effectiveness of endomicroscopy for the in vivo diagnosis of eosinophilic esophagitis

  November 2010 - November 2012

Secondary Outcomes (1)

• Differentiation of mucosal alterations in patients with eosinophilic esophagitis compared to patients with gastroesophageal reflux disease.

  November 2010 - November 2012

Study Arms (2)

Control patients

Device: Confocal laser endomicroscopy

Patients with eosinophilic esophagitis

Device: Confocal laser endomicroscopy

Interventions

Confocal laser endomicroscopy DEVICE

Confocal laser endomicroscopy

Control patients; Patients with eosinophilic esophagitis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University of Erlangen-Nuremberg

Erlangen, Bavaria, 91054, Germany

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Markus F. Neurath, M.D., Ph.D.

  University of Erlangen-Nürnberg

  STUDY DIRECTOR

• Helmut Neumann, M.D., Ph.D.

  University of Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: November 4, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

DE (1)