Confocal Laser Endomicroscopy in Patients With Eosinophilic Esophagitis

Completed

• Conditions: Eosinophilic Esophagitis
• Interventions: Device: Confocal laser endomicroscopy

• Registration Number: NCT01234376
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-02
• Study First Submitted QC: 2010-11-02
• Study First Posted: 2010-11-04
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with eosinophilic esophagitis	Confocal laser endomicroscopy	-
Control patients	Confocal laser endomicroscopy	-

Primary Outcome Measures

Name	Time	Method
Effectiveness of endomicroscopy for the in vivo diagnosis of eosinophilic esophagitis	November 2010 - November 2012

Secondary Outcome Measures

Name	Time	Method
Differentiation of mucosal alterations in patients with eosinophilic esophagitis compared to patients with gastroesophageal reflux disease.	November 2010 - November 2012

Trial Locations

Locations (1)

University of Erlangen-Nuremberg; 🇩🇪 Erlangen, Bayern, Germany