Methylene Blue Chromoendoscopy in Barrett's Esophagus

Completed

• Conditions: Barrett Esophagus

• Registration Number: NCT00587652
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2002-12
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-07
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-05
• Last Update Posted: 2010-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any dysplasia or adenocarcinoma detected over all biopsies using each method.	one year

Secondary Outcome Measures

Name	Time	Method
The association between staining patterns and histologic grade of the biopsies obtained using methylene blue will be assessed.	One year

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States