Methylene Blue Chromoendoscopy in Barrett's Esophagus

January 5, 2010 updated by: Mayo Clinic

A Prospective Trial of 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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
Intermediate Segment Barrett's (2-4cm)
2
Long segment Barrett's (>4 cm)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Christopher G Gostout, MD, Mayo Clinic, Rochester, MN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

January 7, 2008

Study Record Updates

Last Update Posted (Estimate)

January 6, 2010

Last Update Submitted That Met QC Criteria

January 5, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2114-02
  • IRUSEOMO164

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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