Confocal Laserscanning Microscopy for Detection of Barretts Esophagus

Not Applicable

Completed

• Conditions: Barrett Esophagus

• Registration Number: NCT00449995
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-02-23
• Study Start: 2007-03
• Study First Submitted QC: 2007-03-20
• Study First Posted: 2007-03-21
• Primary Completion: 2008-07
• Study Completion: 2008-11
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-23
• Last Update Posted: 2008-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
inter- and intra observer variability for confocal laser scanning microscopy

Trial Locations

Locations (1)

2nd department of the Medical Clinic of the Technical University Munich; 🇩🇪 Munich, Bavaria, Germany