Confocal Laser Endomicroscopy for Improved Diagnosis of Barrett's Esophagus and Associated Neoplasia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia)
研究概览
简要总结
The purpose of this study is to determine if confocal laser endomicroscopy (CLE) can improve detection of Barrett's esophagus, dysplasia, and early esophageal cancer.
详细描述
Barrett's esophagus is a leading cause of esophageal adenocarcinoma. Detection of dysplasia and early cancers in Barrett's esophagus can be challenging, time-consuming and expensive. Small lesions may be difficult to detect with standard endoscopy protocols. Confocal laser endomicroscopy (CLE) is a new type of endoscopy where a small confocal microscope is built into the tip of a standard endoscope. For this study, we are comparing confocal laser endomicroscopy (CLE) with targeted biopsies with standard endoscopy (EGD)and biopsy for Barrett's esophagus to determine if CLE is more effective for detecting dysplasia and cancer.
Participants with Barrett's esophagus in this study undergo 1) CLE with targeted mucosal biopsies (biopsy only taken if CLE shows abnormal tissue) and 2) standard EGD with biopsies. The order of procedures is randomized (some patients have CLE first while others have standard EGD first).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Barrett's esophagus or suspected Barrett's-associated neoplasia
- •Age > 18
- •Able to give informed consent
排除标准
- •Known advanced malignant disease
- •Allergy to the fluorescent contrast agent fluorescein sodium
- •Coagulopathy or bleeding disorder
结局指标
主要结局
Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia)
时间窗: 6 weeks
The yield for neoplasia is calculated by the number of biopsies showing neoplasia over the total number of biopsies taken (normal + neoplastic biopsies)
次要结局
- Mean Number of Biopsies Taken in High Risk Patients (Suspected Neoplasia)(6 weeks)
- Mean Number of Biopsies With Neoplasia in High Risk Patients (Suspected Neoplasia)(6 weeks)
- Diagnostic Yield for Neoplasia in Barrett's Surveillance Patients(6 weeks)
- Mean Number of Biopsies With Neoplasia in Barrett's Surveillance Patients(6 weeks)
- Mean Number of Biopsies Taken in Barrett's Surveillance Patients(6 weeks)