Confocal Laserscanning Microscopy for Detection of Barretts Esophagus

Technical University of Munich

Status: Completed

Conditions: Barrett Esophagus

Treatments: Procedure: confocal laser microscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT00449995

1129/04

Details and patient eligibility

About

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.

Enrollment: 73 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind