Methylene Blue Chromoendoscopy in Barrett's Esophagus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00587652
Recruitment Status : Completed
First Posted : January 7, 2008
Last Update Posted : January 6, 2010
Information provided by:
Mayo Clinic

December 21, 2007
January 7, 2008
January 6, 2010
December 2002
December 2009   (Final data collection date for primary outcome measure)
Any dysplasia or adenocarcinoma detected over all biopsies using each method. [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT00587652 on Archive Site
The association between staining patterns and histologic grade of the biopsies obtained using methylene blue will be assessed. [ Time Frame: One year ]
Same as current
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Methylene Blue Chromoendoscopy in Barrett's Esophagus
A Prospective Trial of Methylene Blue Chromoendoscopy in Barrett's Esophagus

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.

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.
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients presenting for surveillance upper endoscopy to assess Barrett's esophagus.
Barrett Esophagus
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  • 1
    Intermediate Segment Barrett's (2-4cm)
  • 2
    Long segment Barrett's (>4 cm)

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2009
December 2009   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Christopher J. Gostout MD, Mayo Clinic
Mayo Clinic
Principal Investigator: Christopher G Gostout, MD Mayo Clinic, Rochester, MN
Mayo Clinic
January 2010