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临床试验/NCT01504971
NCT01504971Unknown不适用

Diagnostic Value of Narrow-band Imaging, Autofluorescence Imaging & White-light Imaging on Gastroesophageal Reflux Disease

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
95
试验地点
1
主要终点
Diagnostic Ability of Each Endoscopic Finding for GERD Symptom.

研究概览

简要总结

Aim of this study is to compare the efficacy of narrow band imaging (NBI) and autofluorescence imaging (AFI) to distinguish subtle mucosal change related to acid reflux that is not visible in standard white light imaging (WLI) endoscopy, and help indicating the diagnosis of gastroesophageal reflux disease (GERD).

详细描述

GERD is a common condition that develops when the reflux of gastric and/or duodenal contents causes troublesome symptoms with or without mucosal damage or complications. Despite the high prevalence of GERD in the general population, up to 60% of patients with reflux symptoms is insufficiently characterized as having normal endoscopic finding based on standard WLI endoscopy: non-erosive reflux diseases (NERD).

NBI is an optical-digital imaging technology that uses two specific narrow-banded shot wavelength lights (400-430 nm and 525-555 nm) instead of broad band white light. The NBI contrasts surface structure and vascular architecture of the superficial mucosa and facilitates evaluation of indistinct mucosal morphology. AFI produces real-time computed images of endoscopically detected autofluorescence emitted from endogenous fluorophores in the digestive tract (collagen, nicotinamide, adenine dinucleotide, flavin, and porphyrins) caused by light excitation. The AFI can identify lesions due to differences in tissue fluorescence properties that are not detectable by standard WLI. Hence, our hypothesis is that new endoscopic imaging i.e. NBI and AFI would help to identify subtle mucosal change which indicates the diagnosis of GERD

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Gastroesophageal reflux disease (GERD)

干预措施: symptom questionaire (Other)

Gastroesophageal reflux disease (GERD)

干预措施: pH monitoring (Procedure)

Gastroesophageal reflux disease (GERD)

干预措施: Tri-modal imaging endoscopy (Procedure)

Gastroesophageal reflux disease (GERD)

干预措施: rabeprazole (Drug)

结局指标

主要结局

Diagnostic Ability of Each Endoscopic Finding for GERD Symptom.

时间窗: 1 month

Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month

次要结局

  • Association of Each Endoscopic Finding With pH Monitoring Result(1 month)
  • Association of Each Endoscopic Finding With Symptom Score(1 month)
  • Association of Each Endoscopic Finding With Treatment Effect of PPI(2 month)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yunsheng Yang

Professor, Department of Gastroenterology and Hepatology

Chinese PLA General Hospital

研究点 (1)

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