Diagnostic Value of Flexible Spectral Imaging Color Enhancement (FICE) Plus Probe-based Confocal Laser Endomicroscopy (pCLE) for Minimal Change Esophageal Reflux Disease (MERD) Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Interobserver agreement in pCLE for MERD diagnosis
研究概览
简要总结
Gastroesophageal reflux disease (GERD) patients without obvious mucosal break by endoscopy were examined by FICE, followed by confocal. Validity scores for MERD diagnosis were analyzed.
详细描述
Thirty-six patients with suspected MERD (positive GerdQ but normal conventional endoscopy) and eighteen asymptomatic control were recruited. The new FICE (EPX-4450HD) was performed at non-magnified, x50, and x100 zoom levels. The criteria for positive FICE were; A) triangular indentation, B) punctuate erythema, C) villiform mucosa, or D) increased number of capillary vessel. At the same session, pCLE was applied to count the number of intrapapillary capillary loops (IPCLs) by using more than 5 IPCLs in 500x500 micron area as a criterion for MERD diagnosis. The validity scores of both modalities and interobserever agreement of pCLE interpretation was assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •age more than 18 year old
- •no PPI therapy in previous 2 weeks and
- •no esophageal tumor or stenosis or history of esophageal surgery.
排除标准
- •bleeding tendency including decompensated cirrhosis, chronic kidney disease
- •long term antiplatelets or anticoagulants,
- •pregnancy or
- •history of fluorescein allergy.
研究组 & 干预措施
Control
18 control patients were were examined by FICE and then followed by pCLE to evaluate minimal change esophagitis
干预措施: Endoscopy (FICE and pCLE) (Device)
GERD patient
36 GERD patients without obviously abnormality were examined by FICE and then followed by pCLE to evaluate minimal change esophagitis
干预措施: Endoscopy (FICE and pCLE) (Device)
结局指标
主要结局
Interobserver agreement in pCLE for MERD diagnosis
时间窗: 8 months
MERD diagnosis from FICE plus pCLE.
时间窗: 8 months
次要结局
未报告次要终点
研究者
Rapat Pittayanon, MD
Gastrointestinal Unit, King Chulalongkorn Memorial Hospital
King Chulalongkorn Memorial Hospital
