Methylene Blue Chromoendoscopy in Barrett's Esophagus
This study has been completed.
Sponsor:
Mayo Clinic
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
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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:
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 (Adult, Senior) |
| 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
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:
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.
| 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 |
ClinicalTrials.gov processed this record on September 23, 2016