Methylene Blue Chromoendoscopy in Barrett's Esophagus - Full Text View

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

ChemIDplus related topics:

Methylene blue

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	157
Study Start Date:	December 2002
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	December 2008 (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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587652

Contacts


Contact: Mary A Knipschield	507-266-3972	knipschield.mary@mayo.edu

Contact: Debbra K Stark	507-266-1521	stark.debbra@mayo.edu

Locations


United States, Minnesota
	Mayo Clinic	Recruiting
	Rochester, Minnesota, United States, 55902
	Sub-Investigator: Kenneth W Wang, MD
	Principal Investigator: Prabhleen Chahal, MBBS
	Sub-Investigator: Louis M Wong Kee Song, MD
	Sub-Investigator: Navtej S Buttar, MD
	Sub-Investigator: Todd H Baron, MD
	Sub-Investigator: Diahann L Seaman, MD
	Sub-Investigator: Elizabeth Rajan, MD
	Sub-Investigator: Jonathan E Clain, MD
	Sub-Investigator: Kenneth W Schroeder, MD
	Sub-Investigator: Bret T Petersen, MD
	Sub-Investigator: Thomas C Smyrk, MD
	Sub-Investigator: Mark V Larson, MD

Sponsors and Collaborators

Mayo Clinic

AstraZeneca

Investigators


Principal Investigator:	Christopher G Gostout, MD	Mayo Clinic, Rochester, MN

More Information

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

Publications:

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

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.

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.

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. No abstract available.

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

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.

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.

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

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.

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.

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

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.

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.

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.

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

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

Responsible Party:	Mayo Clinic ( Christopher J. Gostout MD )
Study ID Numbers:	2114-02, IRUSEOMO164
First Received:	December 21, 2007
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00587652
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mayo Clinic:

Barrett Esophagus

Methylene blue

Chromoendoscopy

Study placed in the following topic categories:

Digestive System Diseases

Digestive System Abnormalities

Esophageal disorder

Gastrointestinal Diseases

Barrett Esophagus

Esophageal Diseases

Congenital Abnormalities

Methylene Blue

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

Sponsors and Collaborators:	Mayo Clinic AstraZeneca
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00587652