Evaluation of the Diagnostic Ability of White Light Endoscopy and Magnifying Endoscopy With Optical Enhancement System in Early Gastric Cancer and Intraepithelial Neoplasia: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- detection rate of GIN and EGC
研究概览
简要总结
The purpose of this study is to valuation of the diagnostic ability of white light imaging and magnifying endoscopy with optical enhancement system in early gastric cancer and intraepithelial neoplasia.
详细描述
Stomach cancer is the second most common cause of cancer death. Endoscopic identification and treatment of gastric intestinal metaplasia (GIM) and early gastric cancer (EGC) is essential to improve patients' 5-year survival rates. Conventional endoscopy with white light imaging (WLI) is widely used for endoscopic evaluation of EGCs. However, conventional endoscopic visualization of EGCs has a high rate of interobserver variability and correlates poorly with the histological findings. For this reason, diagnosis has been based mostly on repeated endoscopy with multiple biopsy samples. It has been reported that optical enhancement (OE) system is useful for discriminating cancerous lesions from non-cancerous lesions. The OE system is the newly developed image-enhanced endoscopic technology, which combines high definition white light endoscopy (WLE) and optical filters that limit the spectral characteristics of the illumination light. The optical filters can achieve higher overall transmittance by connecting the peaks of the hemoglobin absorption spectrum creating a continuous wavelength spectrum. Magnifying endoscopy is useful for observing the mucosal structures and microvessels. The VS theory proposed by Yao K is widely used in Magnifying endoscopy with optical enhancement system (ME-OE). Based on technical considerations, it is conceivable that ME-OE imaging techniques might have a distinct advantage over WLE in the diagnosis of endoscopic lesions. However, few reports have objectively proved that ME-OE is superior to WLE in the detection rate and diagnostic efficiency of EGCs.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-80 years with H. pylori infection or histologically verified gastric lesions (chronic atrophic gastritis, intestinal metaplasia, GIN or EGC)
- •Or patients aged 40-80 years from a region with high incidence of gastric cancer
- •Or patients aged 40-80 years with first-degree relative of patients with gastric cancer
- •Or patients aged 40-80 years with high-risk factors for gastric cancer (high salt or pickle diet or smoking or heavy drinking)
排除标准
- •A history of gastrectomy
- •Active gastrointestinal bleeding or advanced gastric carcinoma
- •Coagulopathy or severe underlying diseases
- •Pregnancy or lactation
- •Absence of informed consent
结局指标
主要结局
detection rate of GIN and EGC
时间窗: 3 months
The primary outcome was the detection rate of gastric intestinal metaplasia (GIM) and early gastric cancer (EGC) in a per-patient analysis.
次要结局
- sensitivity, specificity of diagnostic performances of GIN and EGC(3 months)
- positive predictive value of diagnostic performances of GIN and EGC(3 months)
- negative predictive value of diagnostic performances of GIN and EGC(3 months)
- diagnostic accuracy in a per-biopsy analysis(3 months)
研究者
Yanqing Li
doctoral supervisor of Qilu Hospital gastroenterology department
Shandong University