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.
Primary Outcome Measures:
- Any dysplasia or adenocarcinoma detected over all biopsies using each method. [ Time Frame: one year ]
Secondary Outcome Measures:
- The association between staining patterns and histologic grade of the biopsies obtained using methylene blue will be assessed. [ Time Frame: One year ]
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| Enrollment: |
100 |
| Study Start Date: |
December 2002 |
| Study Completion Date: |
December 2009 |
| Primary Completion Date: |
December 2009 (Final data collection date for primary outcome measure) |
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1
Intermediate Segment Barrett's (2-4cm)
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2
Long segment Barrett's (>4 cm)
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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.
