Acetic Acid Guided Biopsies Compared With High Definition Endoscopy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- diagnostic yield of targeted biopsies with high definition endoscopy using i scan virtual chromoendoscopy and acetic acid guided biopsies
研究概览
简要总结
Specialized columnar epithelium (SCE) is considered as pathognomonic for Barrett's esophagus. Chromoendoscopy after local acetic acid application enables recognition of the mucosal surface architecture. The new available EPKi processor (Pentax, Japan) enables HD+ resolution above HDTV standard. Aim of the study is to test the efficacy of HD+ endoscopy in conjunction with i-Scan or acetic acid to diagnose Barrett's esophagus. The primary endpoint of the current prospective study is to investigate the diagnostic yield of virtual chromoendoscopy using the i scan function as compared to acetic acid chromoendoscopy and 4-quadrant biopsies.
Patients with visible columnar lined lower esophagus (CLE) are included. After standardized PPI therapy (14 days; standard dosage) patients were randomized at a 1:1 ratio to undergo either chromoendoscopy in conjunction with acetic acid application or i-Scan. Biopsies are taken in a targeted fashion using acetic acid or i scan and afterwards 4-quadrant biopsies are taken.
详细描述
Specialized columnar epithelium (SCE) is considered as pathognomonic for Barrett's esophagus and can be recognized by new endoscopic techniques. Aim of the study is to test the efficacy of HD+ endoscopy in conjunction with i-scan (newly developed post processing digital filter) or chromoendoscopy (acetic acid) to diagnose Barrett's esophagus.
Patients with visible columnar lined lower esophagus (CLE) or known Barrett's esophagus are included. After standardized PPI therapy (14 days; standard dosage) patients are randomized at a 1:1 ratio to undergo either chromoendoscopy in conjunction with acetic acid application (10-15ml; 1.5%) or HD+ endoscopy in conjunction with i-scan. Mucosal surface structure within CLE is graduated according to Guelrud's classification (type 1-2: endoscopic prediction: gastric epithelium; type 3-4: Barrett's epithelium). Biopsies are taken in a targeted fashion (type 1-4) in both groups and subsequently 4-quadrant biopsies were taken. Primary outcome analysis's to investigate the diagnostic yield of the different biopsy protocols.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •patients with CLE
- •patients with known Barrett's esophagus
排除标准
- •pregnancy
- •severe coagulopathy
- •known malignancies
结局指标
主要结局
diagnostic yield of targeted biopsies with high definition endoscopy using i scan virtual chromoendoscopy and acetic acid guided biopsies
时间窗: one year
次要结局
未报告次要终点
研究者
Hoffman Arthur
principal investigator
Johannes Gutenberg University Mainz
