Clinical trial · Observational
Methylene Blue Chromoendoscopy in Barrett's Esophagus
A Prospective Trial of Methylene Blue Chromoendoscopy in Barrett's Esophagus
NCT00587652CI-TRIAL-00002969completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- 1
- description
- Intermediate Segment Barrett's (2-4cm)
- label
- 2
- description
- Long segment Barrett's (\>4 cm)
Primary outcomes (1)
- measure
- Any dysplasia or adenocarcinoma detected over all biopsies using each method.
- timeFrame
- one year
Secondary outcomes (1)
- measure
- The association between staining patterns and histologic grade of the biopsies obtained using methylene blue will be assessed.
- timeFrame
- One year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (22)
- BACKGROUNDRajan 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
- BACKGROUNDGopal 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
- BACKGROUNDCanto 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
- BACKGROUNDWeston 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
- BACKGROUNDFennerty 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
- BACKGROUNDCanto 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
- BACKGROUNDCanto 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