Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Methylene Blue Chromoendoscopy in Barrett's Esophagus

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587652
First received: December 21, 2007
Last updated: January 5, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition
Barrett Esophagus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Trial of Methylene Blue Chromoendoscopy in Barrett's Esophagus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Any dysplasia or adenocarcinoma detected over all biopsies using each method. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The association between staining patterns and histologic grade of the biopsies obtained using methylene blue will be assessed. [ Time Frame: One year ] [ Designated as safety issue: No ]
Enrollment: 100
Study Start Date: December 2002
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Intermediate Segment Barrett's (2-4cm)
2
Long segment Barrett's (>4 cm)

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587652

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Sponsors and Collaborators
Mayo Clinic
AstraZeneca
Investigators
Principal Investigator: Christopher G Gostout, MD Mayo Clinic, Rochester, MN
  More Information

Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

Publications:
Canto M, Wu T, Kalloo A. High Magnification Endoscopy with Methylene Blue Chromoendoscopy for Improved Diagnosis of Barrett's Esophagus and Dysplasia. Gastrointestinal Endoscopy 2001;53(5):AB4171.
Sueoka N, Tabuchi M, Nishigaki H, Sakamoto C, Kobayashi M, Sasajima K. Magnification Endoscopy with Vital Dye Staining For Detection Of A Minute Focus of Early Adenocarcinoma In Barrett's Esophagus. Gastrointestinal Endoscopy 2001;53(5):AB4139.
Breyer H, Maguilnik I, Barros S. Methylene Blue Can Disclose Intestinal Metaplasia In Barrett's Esophagus? Gastrointestinal Endoscopy 2000;51(4):AB3521.
Katzka DA, Rustgi AK. Gastroesophageal reflux disease and Barrett's esophagus. Medical Clinics of North America 2000;84(5):1137-61.

Responsible Party: Christopher J. Gostout MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587652     History of Changes
Other Study ID Numbers: 2114-02, IRUSEOMO164
Study First Received: December 21, 2007
Last Updated: January 5, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Barrett Esophagus
Methylene blue
Chromoendoscopy

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
 Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 25, 2015