Methylene Blue Chromoendoscopy in Barrett's Esophagus
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 Intermediate Segment Barrett's (2-4cm) |
|
| 2 Long segment Barrett's (>4 cm) |
Outcome Measures
Primary Outcome Measures
- Any dysplasia or adenocarcinoma detected over all biopsies using each method. [one year]
Secondary Outcome Measures
- The association between staining patterns and histologic grade of the biopsies obtained using methylene blue will be assessed. [One year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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History of Barrett's with or without dysplasia
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Able to give consent
Exclusion Criteria:
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Pregnancy or women of child-bearing potential
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Active esophagitis
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Esophageal varices
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Esophageal cancer (history of or current)
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Hypersensitivity to methylene blue
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Severe renal impairment (creatinine>2.0)
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Known glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
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Symptomatic coronary artery disease
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Coagulopathy (INR>/=1.5)
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Thrombocytopenia </= 20K/ul
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Previous esophageal ablative therapy (EMR,PDT, APC)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55902 |
Sponsors and Collaborators
- Mayo Clinic
- AstraZeneca
Investigators
- Principal Investigator: Christopher G Gostout, MD, Mayo Clinic, Rochester, MN
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Breyer HP, Silva De Barros SG, Maguilnik I, Edelweiss MI. Does methylene blue detect intestinal metaplasia in Barrett's esophagus? Gastrointest Endosc. 2003 Apr;57(4):505-9.
- 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.
- Canto MI, Setrakian S, Petras RE, Blades E, Chak A, Sivak MV Jr. Methylene blue selectively stains intestinal metaplasia in Barrett's esophagus. Gastrointest Endosc. 1996 Jul;44(1):1-7.
- Canto MI, Setrakian S, Willis J, Chak A, Petras R, Powe NR, Sivak MV Jr. Methylene blue-directed biopsies improve detection of intestinal metaplasia and dysplasia in Barrett's esophagus. Gastrointest Endosc. 2000 May;51(5):560-8.
- Canto MI, Setrakian S, Willis JE, Chak A, Petras RE, Sivak MV. Methylene blue staining of dysplastic and nondysplastic Barrett's esophagus: an in vivo and ex vivo study. Endoscopy. 2001 May;33(5):391-400.
- Canto MI, Yoshida T, Gossner L. Chromoscopy of intestinal metaplasia in Barrett's esophagus. Endoscopy. 2002 Apr;34(4):330-6. Review.
- Canto MI. Chromoendoscopy and magnifying endoscopy for Barrett's esophagus. Clin Gastroenterol Hepatol. 2005 Jul;3(7 Suppl 1):S12-5. Review.
- Canto MI. Methylene blue chromoendoscopy for Barrett's esophagus: coming soon to your GI unit? Gastrointest Endosc. 2001 Sep;54(3):403-9.
- Canto MI. Vital staining and Barrett's esophagus. Gastrointest Endosc. 1999 Mar;49(3 Pt 2):S12-6.
- Fennerty MB, Sampliner RE, McGee DL, Hixson LJ, Garewal HS. Intestinal metaplasia of the stomach: identification by a selective mucosal staining technique. Gastrointest Endosc. 1992 Nov-Dec;38(6):696-8.
- Gangarosa LM, Halter S, Mertz H. Methylene blue staining and endoscopic ultrasound evaluation of Barrett's esophagus with low-grade dysplasia. Dig Dis Sci. 2000 Feb;45(2):225-9.
- Goldman AI. Issues in designing sequential stopping rules for monitoring side effects in clinical trials. Control Clin Trials. 1987 Dec;8(4):327-37.
- Gopal DV. Another look at Barrett's esophagus. Current thinking on screening and surveillance strategies. Postgrad Med. 2001 Sep;110(3):57-8, 61-2, 65-8. Review.
- Hackelsberger A, Günther T, Schultze V, Manes G, Dominguez-Muñoz JE, Roessner A, Malfertheiner P. Intestinal metaplasia at the gastro-oesophageal junction: Helicobacter pylori gastritis or gastro-oesophageal reflux disease? Gut. 1998 Jul;43(1):17-21.
- Katzka DA, Rustgi AK. Gastroesophageal reflux disease and Barrett's esophagus. Med Clin North Am. 2000 Sep;84(5):1137-61. Review.
- Kiesslich R, Hahn M, Herrmann G, Jung M. Screening for specialized columnar epithelium with methylene blue: chromoendoscopy in patients with Barrett's esophagus and a normal control group. Gastrointest Endosc. 2001 Jan;53(1):47-52.
- Montgomery E, Bronner MP, Goldblum JR, Greenson JK, Haber MM, Hart J, Lamps LW, Lauwers GY, Lazenby AJ, Lewin DN, Robert ME, Toledano AY, Shyr Y, Washington K. Reproducibility of the diagnosis of dysplasia in Barrett esophagus: a reaffirmation. Hum Pathol. 2001 Apr;32(4):368-78.
- Rajan E, Burgart LJ, Gostout CJ. Endoscopic and histologic diagnosis of Barrett esophagus. Mayo Clin Proc. 2001 Feb;76(2):217-25.
- Sharma P, Topalovski M, Mayo MS, Weston AP. Methylene blue chromoendoscopy for detection of short-segment Barrett's esophagus. Gastrointest Endosc. 2001 Sep;54(3):289-93.
- Tabuchi M, Sueoka N, Fujimori T. Videoendoscopy with vital double dye staining (crystal violet and methylene blue) for detection of a minute focus of early stage adenocarcinoma in Barrett's esophagus: a case report. Gastrointest Endosc. 2001 Sep;54(3):385-8.
- Weston AP, Krmpotich PT, Cherian R, Dixon A, Topalosvki M. Prospective long-term endoscopic and histological follow-up of short segment Barrett's esophagus: comparison with traditional long segment Barrett's esophagus. Am J Gastroenterol. 1997 Mar;92(3):407-13.
- Wo JM, Ray MB, Mayfield-Stokes S, Al-Sabbagh G, Gebrail F, Slone SP, Wilson MA. Comparison of methylene blue-directed biopsies and conventional biopsies in the detection of intestinal metaplasia and dysplasia in Barrett's esophagus: a preliminary study. Gastrointest Endosc. 2001 Sep;54(3):294-301.
- 2114-02
- IRUSEOMO164