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临床试验/NCT01688687
NCT01688687已完成不适用

The Accuracy of Probe-based Confocal Endomicroscopy Versus Conventional Biopsies for the Diagnosis of Superficial Gastric Neoplasias

Soonchunhyang University Hospital1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
1
主要终点
The accuracy of pCLE compared to conventional forceps biopsy

研究概览

简要总结

Confocal endomicroscopy (CLE) allows real-time in-vivo high-resolution and high-magnification imaging of the gastrointestinal epithelium, which is comparable to histopathology. Previous studies have investigated the accuracy of pCLE for diagnosis and differentiated of colorectal polyps, Barrett's esophagus and pancreaticobiliary strictures. However, to date there are limited data exploring the application of pCLE to gastric lesions, and this is the first study comparing the diagnosis of conventional forceps biopsy with that of pCLE using the final specimens obtained from endoscopic resection as a reference standard. The aims of this study were (1) the accuracy of pCLE compared to conventional forceps biopsy using histopathology results following endoscopic resection as a reference, and (2) comparison of "real time" in-vivo pCLE diagnosis with that of blinded "off-line" pCLE diagnosis, and off-line interobserver agreement.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with biospy proven superficial gastric neoplasia, suitable for endoscopic resection.

排除标准

  • Patients with uncorrectable coagulopathy,
  • liver cirrhosis,
  • acute gastrointestinal bleeding,
  • pregnancy,
  • breast feeding,
  • documented allergy to fluorescein,
  • patients with lesions that were deemed unsuitable for endoscopic resection, and
  • patients without documented conventional biopsy results.

结局指标

主要结局

The accuracy of pCLE compared to conventional forceps biopsy

时间窗: in-vivo pCLE accuracy compared to conventional forceps biopsy was assessed 1-2 weeks prior to endoscopic resection.

The accuracy of pCLE compared to conventional forceps biopsy was assessed using histopathology results following endoscopic resection as a reference

次要结局

  • Comparison of "real time" in-vivo pCLE diagnosis with that of blinded "off-line" pCLE diagnosis.(1-3 months after endoscopic resection and final histopathological analysis)
  • Off-line pCLE interobserver agreement(1-3 months after endoscopic resection and final histopathological analysis)

研究者

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

Gene Hyun Bok

M.D.

Soonchunhyang University Hospital

研究点 (1)

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