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

Brief Summary:

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
Barrett Esophagus

Detailed Description:
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.

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intermediate Segment Barrett's (2-4cm)
Long segment Barrett's (>4 cm)

Primary Outcome Measures :
  1. Any dysplasia or adenocarcinoma detected over all biopsies using each method. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. The association between staining patterns and histologic grade of the biopsies obtained using methylene blue will be assessed. [ Time Frame: One year ]

Information from the National Library of Medicine

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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
Study Population
Patients presenting for surveillance upper endoscopy to assess Barrett's esophagus.

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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00587652

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Christopher G Gostout, MD Mayo Clinic, Rochester, MN

Additional Information:
Canto M, Wu T, Kalloo A. High Magnification Endoscopy with Methylene Blue Chromoendoscopy for Improved Diagnosis of Barrett's Esophagus and Dysplasia. Gastrointestinal Endoscopy 2001;53(5):AB4171.
Sueoka N, Tabuchi M, Nishigaki H, Sakamoto C, Kobayashi M, Sasajima K. Magnification Endoscopy with Vital Dye Staining For Detection Of A Minute Focus of Early Adenocarcinoma In Barrett's Esophagus. Gastrointestinal Endoscopy 2001;53(5):AB4139.
Breyer H, Maguilnik I, Barros S. Methylene Blue Can Disclose Intestinal Metaplasia In Barrett's Esophagus? Gastrointestinal Endoscopy 2000;51(4):AB3521.

Responsible Party: Christopher J. Gostout MD, Mayo Clinic Identifier: NCT00587652     History of Changes
Other Study ID Numbers: 2114-02
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

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