Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2002-12-31
2009-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Intermediate Segment Barrett's (2-4cm)
No interventions assigned to this group
2
Long segment Barrett's (\>4 cm)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Able to give consent
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Mayo Clinic
OTHER
Responsible Party
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Mayo Clinic
Principal Investigators
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Christopher G Gostout, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic, Rochester, MN
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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Rajan E, Burgart LJ, Gostout CJ. Endoscopic and histologic diagnosis of Barrett esophagus. Mayo Clin Proc. 2001 Feb;76(2):217-25. doi: 10.1016/S0025-6196(11)63133-9.
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. doi: 10.3810/pgm.2001.09.1018.
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. doi: 10.1016/s0016-5107(96)70221-3.
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.
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. doi: 10.1016/s0016-5107(92)70567-7. No abstract available.
Canto MI. Vital staining and Barrett's esophagus. Gastrointest Endosc. 1999 Mar;49(3 Pt 2):S12-6. doi: 10.1016/s0016-5107(99)70518-3. No abstract available.
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. doi: 10.1016/s0016-5107(00)70290-2.
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. doi: 10.1067/mge.2001.111041.
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. doi: 10.1067/mge.2001.115728.
Canto MI, Yoshida T, Gossner L. Chromoscopy of intestinal metaplasia in Barrett's esophagus. Endoscopy. 2002 Apr;34(4):330-6. doi: 10.1055/s-2002-23640. No abstract available.
Canto MI. Methylene blue chromoendoscopy for Barrett's esophagus: coming soon to your GI unit? Gastrointest Endosc. 2001 Sep;54(3):403-9. doi: 10.1067/mge.2001.117958. No abstract available.
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. doi: 10.1067/mge.2001.115732.
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. doi: 10.1067/mge.2001.116458. No abstract available.
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. doi: 10.1023/a:1005479619246.
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. doi: 10.1067/mge.2003.137.
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. doi: 10.1053/hupa.2001.23510.
Katzka DA, Rustgi AK. Gastroesophageal reflux disease and Barrett's esophagus. Med Clin North Am. 2000 Sep;84(5):1137-61. doi: 10.1016/s0025-7125(05)70280-7.
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. doi: 10.1055/s-2001-14427.
Hackelsberger A, Gunther T, Schultze V, Manes G, Dominguez-Munoz 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. doi: 10.1136/gut.43.1.17.
Goldman AI. Issues in designing sequential stopping rules for monitoring side effects in clinical trials. Control Clin Trials. 1987 Dec;8(4):327-37. doi: 10.1016/0197-2456(87)90153-x.
Canto MI. Chromoendoscopy and magnifying endoscopy for Barrett's esophagus. Clin Gastroenterol Hepatol. 2005 Jul;3(7 Suppl 1):S12-5. doi: 10.1016/s1542-3565(05)00289-2.
Other Identifiers
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IRUSEOMO164
Identifier Type: -
Identifier Source: secondary_id
2114-02
Identifier Type: -
Identifier Source: org_study_id
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