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

18 Years
Not Enrolling
Barrett Esophagus

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Trial Information

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

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.

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
- Previous esophageal ablative therapy (EMR,PDT, APC)

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Any dysplasia or adenocarcinoma detected over all biopsies using each method.

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Christopher G Gostout, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic, Rochester, MN


United States: Food and Drug Administration

Study ID:




Start Date:

December 2002

Completion Date:

December 2009

Related Keywords:

  • Barrett Esophagus
  • Barrett Esophagus
  • Methylene blue
  • Chromoendoscopy
  • Barrett Esophagus



Mayo Clinic Rochester, Minnesota  55905