Clinical trial NCT00587652: Methylene Blue Chromoendoscopy in Barrett's Esophagus
Official title: A Prospective Trial of Methylene Blue Chromoendoscopy in Barrett's Esophagus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett Esophagus
Keywords: Barrett Esophagus
Methylene blue
Chromoendoscopy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2008-01-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting for surveillance upper endoscopy to assess Barrett's esophagus.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Any dysplasia or adenocarcinoma detected over all biopsies using each method.
timeFrame: one year
Secondary outcomes:
measure: The association between staining patterns and histologic grade of the biopsies obtained using methylene blue will be assessed.
timeFrame: One year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic, Rochester, MN
name: Christopher G Gostout, MD
role: PRINCIPAL_INVESTIGATOR
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