JPRN-jRCT1032210213已完成2 期
An exploratory randomized controlled trial evaluating the efficacy and safety of third-generation narrow band imaging, texture and color enhancement imaging, and white light imaging in detecting the early gastric cancer and/or gastric adenoma - 3G-detection trial
Yano Tomonori0 个研究点目标入组 901 人开始时间: 2021年7月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 901
研究概览
简要总结
Efficacy analysis (primary endpoint) detection rate of gastric epithelial tumor lesions in non-magnification observation at initial observation (comparison of 3 groups) was Group B (NBI) 7.3% > Group C (TXI) 5.0%, and B Group (NBI) exceeded the control group A (WLI) by 5.6% by more than 1.0%. Based on this, group B (NBI) is a more promising observation method and was judged to be appropriate as the observation group for the next confirmatory study.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •1)Aged 20 to 85 years old at the time of obtaining consent.
- •2)Fulfill any of the following [1]-[3].
- •[1]Have a history of endoscopic treatment for early gastric cancer and/or gastric adenoma, and endoscopic examination is scheduled on the purpose of follow-up.
- •[2]Have a history of endoscopic treatment, chemotherapy, or radiotherapy for esophageal cancer, and endoscopic examination is scheduled on the purpose of follow-up.
- •[3]Has a lesion diagnosed as gastric cancer, gastric adenoma, or esophageal cancer, and endoscopic examination is scheduled on the purpose of detailed examination.
- •3)Written informed consent has been obtained for participation in the study.
排除标准
- •1)Have a history of gastrectomy.
- •2)Have a history of gastric tube reconstruction after esophagectomy.
- •3)Judged as inappropriate for carrying out this study, including the underlying disease.
研究者
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