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Methylene Blue Chromoendoscopy in Barrett's Esophagus

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587652
First received: December 21, 2007
Last updated: January 5, 2010
Last verified: January 2010
History of Changes

December 21, 2007
January 5, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00587652 on ClinicalTrials.gov Archive Site
The association between staining patterns and histologic grade of the biopsies obtained using methylene blue will be assessed. [ Time Frame: One year ] [ Designated as safety issue: No ]
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients presenting for surveillance upper endoscopy to assess Barrett's esophagus.
Barrett Esophagus
Not Provided
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00587652
2114-02, IRUSEOMO164
No
Christopher J. Gostout MD, Mayo Clinic
Mayo Clinic
AstraZeneca
Principal Investigator: Christopher G Gostout, MD Mayo Clinic, Rochester, MN
Mayo Clinic
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP