Application of Linked Color Imaging（LCI） in Diagnosis of Early Gastric Cancer(EGC): a Multicenter,Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- Detection rate of gastric neoplastic lesion
研究概览
简要总结
the purpose of this study is to evaluate application value of LCI in the diagnosis of early gastric cancer.
详细描述
The detection rate of early gastric cancer is still very low in China. The investigators need a new and effective screening method to improve the detection rate. LCI (linked-color imaging)is a new model of laser endoscopy which can provide brighter image. LCI can provide clear image which can make red part redder and white part whiter, so suspicious lesion could be found easier. The study of this randomized controlled trial is to discuss effectiveness of LCI in the diagnosis of early gastric cancer and to find a new method to improve the detection rate of early gastric cancer in China.
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
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •High-risk group of gastric cancer: H. pylori infection; previously suffering from chronic atrophic gastritis, intestinal metaplasia, gastric ulcer, gastric polyps, residual stomach after surgery, hypertrophic gastritis, malignant anemia and other precancerous diseases of gastric cancer;
- •First degree relatives of patients with gastric cancer;
- •There are other high risk factors for gastric cancer (high salt, salted diet, smoking, heavy drinking, etc.).
- •Patients with early gastric cancer treated with endoscopic therapy (ESD, EMR).
- •The informed consent has been signed.
排除标准
- •The TNM classification of cancer is consistent with those diagnosed by T2 above.
- •Patients with abnormal blood coagulation function or taking anticoagulants can not biopsy.
- •There were contraindications for gastroscopy.
- •A patient without self judgement;
- •Those who did not sign informed consent.
- •Previous gastroscopy has found suspicious lesions requiring careful examination.
研究组 & 干预措施
White light
Using white light only.
LCI+white light
Using white light firstly to observe from cardia to duodenum and then switch LCI model to observe from antrum to cardia
干预措施: LCI+white light (Diagnostic Test)
结局指标
主要结局
Detection rate of gastric neoplastic lesion
时间窗: immediately following the procedure
Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma
次要结局
- Sensitivity of detecting gastric neoplastic lesion(immediately following the procedure)
- Specificity of detecting gastric neoplastic lesion(immediately following the procedure)
研究者
Zhaoshen Li
Director of Gastroenterology Dept
Changhai Hospital