Clinical Trial: Methylene Blue Chromoendoscopy in Barrett's Esophagus

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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 Summary: 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.
Sponsor: Mayo Clinic

Current Primary Outcome: Any dysplasia or adenocarcinoma detected over all biopsies using each method. [ Time Frame: one year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The association between staining patterns and histologic grade of the biopsies obtained using methylene blue will be assessed. [ Time Frame: One year ]

Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: December 21, 2007
Date Started: December 2002
Date Completion:
Last Updated: January 5, 2010
Last Verified: January 2010