Influence of Routine Use of Narrow Band Imaging on Heterotopic Gastric Mucosa of the Proximal Esophagus Detection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Detection of heterotopic gastric mucosa in the proximal esophagus
研究概览
简要总结
The aim of the study is to determine whether Narrow Band Imaging(NBI) should be routinely used during esophagus inspection at diagnostic gastroscopy.
详细描述
Heterotopic gastric mucosa, also called inlet patch, is area of ectopic gastric mucosa with common location at proximal part of esophagus. Because of the location, lesions are likely to be missed during routine gastroscopy. The clinical significance of inlet patches remains unknown, however they may be symptomatic and may cause morphologic changes such as strictures, ulcers, webs, stenoses or even adenocarcinomas. Moreover inlet patches may be correlated with reflux symptoms up to 73,1%. Several studies were conducted to determine whether NBI improves detection of cervical inlet patches, some of them were also prospective studies, however no randomized study was conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referral for diagnostic gastroscopy
- •Ability to undergo diagnostic gastroscopy
- •Provided written informed consent
排除标准
- •Prisoners
- •Pregnancy
- •Gastroscopy with treatment procedure
- •Inability to provide informed consent
结局指标
主要结局
Detection of heterotopic gastric mucosa in the proximal esophagus
时间窗: Day 1
次要结局
- Detection of other upper gastrointestinal lesions(Day 1)
- Correlation of throat and esophageal reflux symptoms with cervical inlet patches(Day 1)
- Total and esophagus inspection time(Day 1)
- Rate of cervical inlet patches verified with NBI in endoscopies performed in standard white light endoscopy(Day 1)
- Correlation of subject's subjective purpose of gastroscopy and cervical inlet patch occurrence(Day 1)
研究者
Tomasz Romańczyk
Principal Investigator Tomasz Romańczyk MD, PhD
H-T. Centrum Medyczne Sp. z o.o. sp. k