Methylene Blue Chromoendoscopy in Barrett's Esophagus

NCT00587652 | Completed

• 2 other identifiers: 2114-02IRUSEOMO164
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Barrett Esophagus

Keywords

Barrett Esophagus; Methylene blue; Chromoendoscopy

Outcome Measures

Primary Outcomes (1)

• Any dysplasia or adenocarcinoma detected over all biopsies using each method.

  one year

Secondary Outcomes (1)

• The association between staining patterns and histologic grade of the biopsies obtained using methylene blue will be assessed.

  One year

Study Arms (2)

1

Intermediate Segment Barrett's (2-4cm)

2

Long segment Barrett's (\>4 cm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• History of Barrett's with or without dysplasia
• Able to give consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead
• AstraZeneca: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Related Publications (21)

• 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.

  PMID: 11213314 BACKGROUND

• 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.

  PMID: 11570206 BACKGROUND

• 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.

  PMID: 8836709 BACKGROUND

• 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.

  PMID: 9068459 BACKGROUND

• 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.

  PMID: 1282115 BACKGROUND

• 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.

  PMID: 10049441 BACKGROUND

• 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.

  PMID: 10805842 BACKGROUND

• 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.

  PMID: 11154488 BACKGROUND

• 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.

  PMID: 11522967 BACKGROUND

• 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.

  PMID: 11932792 BACKGROUND

• 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.

  PMID: 11522995 BACKGROUND

• 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.

  PMID: 11522968 BACKGROUND

• 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.

  PMID: 11522988 BACKGROUND

• 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.

  PMID: 10711429 BACKGROUND

• 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.

  PMID: 12665760 BACKGROUND

• 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.

  PMID: 11331953 BACKGROUND

• 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.

  PMID: 11026922 BACKGROUND

• 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.

  PMID: 11396755 BACKGROUND

• 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.

  PMID: 9771400 BACKGROUND

• 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.

  PMID: 3327653 BACKGROUND

• 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.

  PMID: 16012986 BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Christopher G Gostout, MD

  Mayo Clinic, Rochester, MN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: December 1, 2002
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 6, 2010

Record last verified: 2010-01

Locations

US (1)