Methylene Blue Chromoendoscopy in Barrett's Esophagus

Barrett Esophagus Clinical Trial

Official title:

A Prospective Trial of Methylene Blue Chromoendoscopy in Barrett's Esophagus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587652
• Other study ID #: 2114-02
• Secondary ID: IRUSEOMO164
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: January 5, 2010
• Start date: December 2002
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Barrett Esophagus

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	AstraZeneca

Country where clinical trial is conducted

United States, 

References & Publications (22)

Breyer H, Maguilnik I, Barros S. Methylene Blue Can Disclose Intestinal Metaplasia In Barrett's Esophagus? Gastrointestinal Endoscopy 2000;51(4):AB3521.

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. — View Citation

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. — View Citation

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. — View Citation

Canto MI, Yoshida T, Gossner L. Chromoscopy of intestinal metaplasia in Barrett's esophagus. Endoscopy. 2002 Apr;34(4):330-6. Review. — View Citation

Canto MI. Chromoendoscopy and magnifying endoscopy for Barrett's esophagus. Clin Gastroenterol Hepatol. 2005 Jul;3(7 Suppl 1):S12-5. Review. — View Citation

Canto MI. Methylene blue chromoendoscopy for Barrett's esophagus: coming soon to your GI unit? Gastrointest Endosc. 2001 Sep;54(3):403-9. — View Citation

Canto MI. Vital staining and Barrett's esophagus. Gastrointest Endosc. 1999 Mar;49(3 Pt 2):S12-6. — View Citation

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. — View Citation

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. — View Citation

Goldman AI. Issues in designing sequential stopping rules for monitoring side effects in clinical trials. Control Clin Trials. 1987 Dec;8(4):327-37. — View Citation

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. — View Citation

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. — View Citation

Katzka DA, Rustgi AK. Gastroesophageal reflux disease and Barrett's esophagus. Med Clin North Am. 2000 Sep;84(5):1137-61. Review. — View Citation

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. — View Citation

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. — View Citation

Rajan E, Burgart LJ, Gostout CJ. Endoscopic and histologic diagnosis of Barrett esophagus. Mayo Clin Proc. 2001 Feb;76(2):217-25. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any dysplasia or adenocarcinoma detected over all biopsies using each method.		one year	No
Secondary	The association between staining patterns and histologic grade of the biopsies obtained using methylene blue will be assessed.		One year	No

External Links

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