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Confocal Laserscanning Microscopy for Detection of Barretts Esophagus

This study has been completed.
Sponsor:
Collaborators:
Charite University, Berlin, Germany
Dresden University of Technology
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00449995
First received: February 23, 2007
Last updated: December 23, 2008
Last verified: December 2008
History of Changes

February 23, 2007
December 23, 2008
March 2007
July 2008   (final data collection date for primary outcome measure)
diagnostic accuracy of confocal laser scanning microscopy for detection of metaplasia or neoplasia in Barrett´s esophagus
Same as current
Complete list of historical versions of study NCT00449995 on ClinicalTrials.gov Archive Site
inter- and intra observer variability for confocal laser scanning microscopy
Same as current
Not Provided
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Confocal Laserscanning Microscopy for Detection of Barretts Esophagus
Confocal Laserscanning Microscopy for Detection of Barretts Esophagus. A Blinded Multi-Center Study.

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.
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Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Barrett Esophagus
Procedure: confocal laser microscopy
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
November 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00449995
1129/04
Not Provided
Not Provided
Technische Universität München
  • Charite University, Berlin, Germany
  • Dresden University of Technology
Principal Investigator: Alexander Meining, MD Technical University Munich
Technische Universität München
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP