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Completed

NCT Number: NCT00449995

Confocal Laserscanning Microscopy for Detection of Barretts Esophagus

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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Key information

Conditions

Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2nd department of the Medical Clinic of the Technical University Munich

Munich, Bavaria, 81675, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

confocal laser microscopy

Procedure

Primary outcomes

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

Secondary outcomes

  1. inter- and intra observer variability for confocal laser scanning microscopy

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Charite University, Berlin, Germany
  • Technische Universität Dresden

Registry information

Official study title

Confocal Laserscanning Microscopy for Detection of Barretts Esophagus. A Blinded Multi-Center Study.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 21, 2007
Registry last updated
Dec 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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