Photoacoustic Endoscopy of Barrett's Esophagus
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Feasibility of PA endoscopic imaging as an alternative real-time noninvasive tool for evaluation of Barrett's esophagus as measured by the agreement between the PA imaging system and the standard esophageal biopsy for diagnosing Barrett's epithelium
研究概览
简要总结
Endoscopy is an important technique in medicine to diagnose internal organs. Video endoscopy has been the most common technique providing clear, real time video images of organs' surfaces. However, this technique only images the surface and cannot effectively diagnose diseased tissues that develop in endothelial tissues. Endoscopic ultrasound (EUS) has been developed to overcome this limitation, and it is widely utilized in diagnosing GI diseases. This technique can image very deep areas of organs, up to several centimeters; however, it suffers from speckle artifacts and cannot adequately provide early diagnosis of tissue abnormalities that do not show mechanical properties that differ significantly from those of normal tissues.
The investigators propose that photoacoustic endoscopy (PAE), an endoscopic embodiment of the rapidly growing photoacoustic tomography (PAT) technology, can fulfill the aforementioned need.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Aged 18 years and older.
- •Patients with Barrett's esophagus scheduled for esophageal surgery.
- •Patients with GERD, but without Barrett's esophagus, scheduled for esophageal surgery.
- •Subjects must be able to understand and willing to sign a written informed consent form.
排除标准
- •Inability to give informed consent.
- •Pregnancy.
- •Age less than 18 years
- •Previous esophageal procedure (surgery, photodynamic therapy, argon plasma coagulation, endoscopic mucosal resection).
- •Acute GI bleeding.
- •Coagulopathy.
结局指标
主要结局
Feasibility of PA endoscopic imaging as an alternative real-time noninvasive tool for evaluation of Barrett's esophagus as measured by the agreement between the PA imaging system and the standard esophageal biopsy for diagnosing Barrett's epithelium
时间窗: Day 1
-The investigators will image a series of human esophagi in patients with an established diagnosis of Barrett's esophagus with/without dysplasia to fine-tune the PA imaging system. The investigators will assess the agreement between the PA imaging system and the standard clinical practice of four-quadrant esophageal biopsy previously performed in this cohort of patients as part of his/her active surveillance program.
Sensitivity and specificity of PA endoscopic imaging for identification of Barrett's epithelium compared to esophageal biopsy
时间窗: Day 1
-The investigators will image a series of human esophagi in patients with an established diagnosis of Barrett's esophagus with/without dysplasia to fine-tune the PA imaging system. The investigators will assess the agreement between the PA imaging system and the standard clinical practice of four-quadrant esophageal biopsy previously performed in this cohort of patients as part of his/her active surveillance program.
次要结局
未报告次要终点