Confocal Laserscanning Microscopy for Detection of Barretts Esophagus

Technical University of Munich73 enrolled

Overview

Four quadrant biopsies in regular ranges is the goldstandard in monitoring this disease. The ideal situation for the endoscopist is to visualize cellular structures, which implies having microscopic imaging available. A potential candidate to fill this gap could be confocal fluorescence microscopy (Cellvizio®-GI and Mauna Kea Technologies). To compare the gold standard with the confocal fluorescence microscopy for detection of metaplastic - or intraepithelial neoplastic changes of barrett-suspicious esophageal mucosa this study has been initiated.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Barrett Esophagus

Interventions

confocal laser microscopyPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age between 18 and 80 years * regular esophagogastroduodenoscopy for patients with known barrett esophagus (at least stadium C0M1) * patients presenting for endoscopic mucosectomy with intraepithelial neoplastic changes \<1cm * patients presenting with suspected intraepithelial neoplastic changes * patients receiving acid suppressive therapy in standard dose for at least 4 weeks Exclusion Criteria: * no informed consent * thrombocytopenia, quick \<50%, PTT \>50 sec * patients with coronary heart disease or existent valve plasties * women with potential pregnancy * patients with chronic renal failure * patients with allergies * patients with chronic obstructive pulmonary disease

Locations (1)

2nd department of the Medical Clinic of the Technical University Munich

Munich, Bavaria, Germany

Outcomes

Primary Outcomes

diagnostic accuracy of confocal laser scanning microscopy for detection of metaplasia or neoplasia in Barrett´s esophagus

Secondary Outcomes

inter- and intra observer variability for confocal laser scanning microscopy

Data from ClinicalTrials.gov

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