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OpenTrials
Completed

NCT Number: NCT00587652

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.

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Key information

Conditions

Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55902, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

    Time frame: one year

Secondary outcomes

  1. The association between staining patterns and histologic grade of the biopsies obtained using methylene blue will be assessed.

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2009
Study completion
2009
First posted
Jan 7, 2008
Registry last updated
Jan 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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