Confocal Laser Endomicroscopy in Patients With Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

Official title:

Confocal Laser Endomicroscopy in Patients With Eosinophilic Esophagitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234376
• Other study ID #: HN-0003
• Status: Completed
• Start date: November 2010
• Est. completion date: December 2014

Study information

• Verified date: December 2020
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Device:
• Confocal laser endomicroscopy
Confocal laser endomicroscopy

Locations

Country	Name	City	State
Germany	University of Erlangen-Nuremberg	Erlangen	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of endomicroscopy for the in vivo diagnosis of eosinophilic esophagitis		November 2010 - November 2012
Secondary	Differentiation of mucosal alterations in patients with eosinophilic esophagitis compared to patients with gastroesophageal reflux disease.		November 2010 - November 2012