Methylene Blue Chromoendoscopy in Barrett's Esophagus

Completed

Conditions studied: Barrett Esophagus

In brief

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.

Key facts

Study ID

NCT00587652

Run by

Mayo Clinic

People needed

100

Starts

2002-12-01

Expected to finish

2009-12-01

Last updated by the study team

2010-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of Barrett's with or without dysplasia
• Able to give consent

You may not qualify if…

• 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)

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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