跳至主要内容
临床试验/NCT02336100
NCT02336100已完成不适用

Diagnostic Value of Flexible Spectral Imaging Color Enhancement (FICE) Plus Probe-based Confocal Laser Endomicroscopy (pCLE) for Minimal Change Esophageal Reflux Disease (MERD) Diagnosis

King Chulalongkorn Memorial Hospital2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2011年6月最近更新:
适应症
干预措施

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

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

Experimental

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rapat Pittayanon, MD

Gastrointestinal Unit, King Chulalongkorn Memorial Hospital

King Chulalongkorn Memorial Hospital

研究点 (2)

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