Methylene Blue Chromoendoscopy in Barrett's Esophagus
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ClinicalTrials.gov Identifier: NCT00587652 |
Recruitment Status
:
Completed
First Posted
: January 7, 2008
Last Update Posted
: January 6, 2010
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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.
Condition or disease |
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Barrett Esophagus |
Study Type : | Observational |
Actual Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Prospective Trial of Methylene Blue Chromoendoscopy in Barrett's Esophagus |
Study Start Date : | December 2002 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | December 2009 |

Group/Cohort |
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1
Intermediate Segment Barrett's (2-4cm)
|
2
Long segment Barrett's (>4 cm)
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- Any dysplasia or adenocarcinoma detected over all biopsies using each method. [ Time Frame: one year ]
- 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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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00587652
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55902 |
Principal Investigator: | Christopher G Gostout, MD | Mayo Clinic, Rochester, MN |
Additional Information:
Publications:
Responsible Party: | Christopher J. Gostout MD, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00587652 History of Changes |
Other Study ID Numbers: |
2114-02 IRUSEOMO164 |
First Posted: | January 7, 2008 Key Record Dates |
Last Update Posted: | January 6, 2010 |
Last Verified: | January 2010 |
Keywords provided by Mayo Clinic:
Barrett Esophagus Methylene blue Chromoendoscopy |
Additional relevant MeSH terms:
Barrett Esophagus Digestive System Abnormalities Digestive System Diseases Esophageal Diseases |
Gastrointestinal Diseases Methylene Blue Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |