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.

Study Overview

• Status: Completed
• Conditions: Barrett Esophagus
• Intervention / Treatment: Procedure: confocal laser microscopy

• Study Type: Interventional
• Enrollment (Anticipated): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
inter- and intra observer variability for confocal laser scanning microscopy

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Charite University, Berlin, Germany; Technische Universität Dresden
• Investigators: Principal Investigator: Alexander Meining, MD, Technical University Munich

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: February 23, 2007
• First Submitted That Met QC Criteria: March 20, 2007
• First Posted (Estimate): March 21, 2007

Study Record Updates

• Last Update Posted (Estimate): December 24, 2008
• Last Update Submitted That Met QC Criteria: December 23, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: 1129/04