Clinical Trials Directory

Trials / Completed

CompletedNCT00587652

Methylene Blue Chromoendoscopy in Barrett's Esophagus

A Prospective Trial of Methylene Blue Chromoendoscopy in Barrett's Esophagus

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study is being done to: Determine if a temporary dye applied to the esophagus identifies areas of dysplasia (pre-cancer). Determine if certain dye patterns indicate specific grades of dysplasia. Determine if overall endoscopy costs can be reduced with this dye technique. Determine if the dye could allow fewer biopsies to be obtained in the future.

Detailed description

Although methylene blue has been used effectively to identify areas of SIM in several studies, its superiority in identifying dysplasia in the setting of Barrett's esophagus has been inconclusive. In all studies to date dysplastic yield was equivalent or better than protocol techniques while requiring fewer biopsies. Variations in study design, staining technique and inexperience in staining interpretation are some of the reasons. Our goal is to build on the techniques that have been shown to be effective, standardize them for the purposes of our study, and to objectively evaluate if MB directed biopsies are useful in screening Barrett's patients for dysplasia. At the time of EGD when length of Barrett's is determined, patients will be stratified into either intermediate (2-4cm) or long segment (\>4cm) Barrett's. Short segment Barrett's esophagus patients will not be considered, as MB techniques have not proved beneficial in dysplasia detection as previously described 7.

Conditions

Timeline

Start date
2002-12-01
Primary completion
2009-12-01
Completion
2009-12-01
First posted
2008-01-07
Last updated
2010-01-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00587652. Inclusion in this directory is not an endorsement.