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临床试验/NCT05458388
NCT05458388Unknown不适用

Different Endoscopic Gastric Cancer Risk Assessments for the Detection of Early Gastric Cancer

Yanqing Li1 个研究点 分布在 1 个国家目标入组 3,500 人开始时间: 2022年7月12日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
3,500
试验地点
1
主要终点
Early gastric cancer detection rate

研究概览

简要总结

The Kimura-Takamoto classification established in Japan can observe the extent of gastric atrophy in real-time under endoscopy, and diffuse atrophy also indicates an increased risk of gastric cancer. Recent studies have found that the evaluation of intestinal metaplasia score (EGGIM score) of various stomach parts by electronic staining can well identify OLGIM III\ IV patients. Although the Kimura-Takamoto classification and EGGIM score can evaluate the risk of gastric cancer in patients, only in cross-sectional studies, it is not clear the diagnostic value of risk assessment in population screening. Early gastric cancer has the characteristics of hidden lesions and a high rate of clinical missed diagnosis. Concentrating high-risk groups through risk scores is expected to guide endoscopic doctors to conduct a targeted careful examination. However, it is not clear whether Kimura-Takamoto classification and EGGIM score can improve the detection rate of early gastric cancer in clinical practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 40-80 years undergoing gastroscopy
  • Patients intend to undergo ESD treatment

排除标准

  • patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in gastroscopy
  • Patients with previous surgical procedures on the stomach
  • patients with contraindications to biopsy
  • Patients who refuse to sign the informed consent form.

结局指标

主要结局

Early gastric cancer detection rate

时间窗: 36 months

The detection rate of early gastric cancer

次要结局

未报告次要终点

研究者

发起方
Yanqing Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yanqing Li

Vice President of Qilu Hospital

Shandong University

研究点 (1)

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