Methylene Blue Chromoendoscopy in Barrett's Esophagus

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Barrett Esophagus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of Barrett's with or without dysplasia Able to give consent Exclusion Criteria: Pregnancy or women of child-bearing potential Active esophagitis Esophageal varices Esophageal cancer (history of or current) Hypersensitivity to methylene blue Severe renal impairment (creatinine>2.0) Known glucose-6-phosphate dehydrogenase (G-6-PD) deficiency Symptomatic coronary artery disease Coagulopathy (INR>/=1.5) Thrombocytopenia </= 20K/ul Previous esophageal ablative therapy (EMR,PDT, APC)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Intermediate Segment Barrett's (2-4cm) | |
| 2<br>Long segment Barrett's (>4 cm) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any dysplasia or adenocarcinoma detected over all biopsies using each method. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The association between staining patterns and histologic grade of the biopsies obtained using methylene blue will be assessed. |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barrett Esophagus, Methylene blue, Chromoendoscopy