Methylene Blue Chromoendoscopy in Barrett's Esophagus

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00587652
• Date of registration: 21/12/2007
• Primary sponsor: Mayo Clinic
• Public title: Methylene Blue Chromoendoscopy in Barrett's Esophagus
• Scientific title: A Prospective Trial of Methylene Blue Chromoendoscopy in Barrett's Esophagus
• Date of first enrolment: December 2002
• Target sample size: 100
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00587652
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective

Countries of recruitment

United States

Contacts

• Name: Christopher G Gostout, MD
• Affiliation: Mayo Clinic, Rochester, MN

Key inclusion & exclusion 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
- Previous esophageal ablative therapy (EMR,PDT, APC)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Barrett Esophagus

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

2114-02

IRUSEOMO164

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AstraZeneca