A Prospective Trial of Methylene Blue Chromoendoscopy in Barrett's Esophagus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Any dysplasia or adenocarcinoma detected over all biopsies using each method.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of Barrett's with or without dysplasia
- •Able to give consent
排除标准
- •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)
结局指标
主要结局
Any dysplasia or adenocarcinoma detected over all biopsies using each method.
时间窗: one year
次要结局
- The association between staining patterns and histologic grade of the biopsies obtained using methylene blue will be assessed.(One year)