Confocal Laserscanning Microscopy for Detection of Barretts Esophagus

This study has been completed.

Sponsors and Collaborators:	Technische Universität München Charite University, Berlin, Germany Dresden University of Technology
Information provided by:	Technische Universität München
ClinicalTrials.gov Identifier:	NCT00449995

Purpose

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.

Condition	Intervention
Barrett Esophagus	Procedure: confocal laser microscopy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Confocal Laserscanning Microscopy for Detection of Barretts Esophagus. A Blinded Multi-Center Study.

Further study details as provided by Technische Universität München:

Primary Outcome Measures:

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

Secondary Outcome Measures:

inter- and intra observer variability for confocal laser scanning microscopy

Estimated Enrollment:	73
Study Start Date:	March 2007
Study Completion Date:	November 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449995

Locations

Germany, Bavaria
2nd department of the Medical Clinic of the Technical University Munich
Munich, Bavaria, Germany, 81675

Sponsors and Collaborators

Technische Universität München

Charite University, Berlin, Germany

Dresden University of Technology

Investigators

Principal Investigator:

Alexander Meining, MD

Technical University Munich

More Information

Study ID Numbers:	1129/04
Study First Received:	February 23, 2007
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00449995
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Abnormalities
Esophageal disorder
Gastrointestinal Diseases

Barrett Esophagus
Esophageal Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on January 14, 2009