Barrett Esophagus
Conditions
Brief summary
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.
Interventions
PROCEDUREconfocal laser microscopy
Sponsors
Charite University, Berlin, Germany
Technische Universität Dresden
Technical University of Munich
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| diagnostic accuracy of confocal laser scanning microscopy for detection of metaplasia or neoplasia in Barrett´s esophagus | — |
Secondary
| Measure | Time frame |
|---|---|
| inter- and intra observer variability for confocal laser scanning microscopy | — |
Countries
Germany
Outcome results
None listed