Miniprobe confocal laser microscopy for the detection of invisible neoplasia in patients with Barrett´s esophagus

Completed

• Conditions: Barrett esophagus; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12608000124336
• Lead Sponsor: Charite University Hospitals Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

All patients with known Barrett esophagus who present for an upper endoscopy (EGD)

Exclusion Criteria

Phase I (establishment of CLM neoplasia criteria) - none.
Phase II (testing of criteria) - only patients with no apparent macroscopic lesions within the Barrett segment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sensitivity and specificity of miniprobe CLM to detect high grade intraepithelial neoplasia or early esophageal adenocarcinoma using histology as the gold standard.[One timepoint, at presentation for screening or surveillance endoscopies.]

Secondary Outcome Measures

Name	Time	Method
interobserver agreement of blindly evaluated CLM recordings.[One timepoint, at presentation for screening or surveillance endoscopies.]