Prospective Controlled Trial of Narrow Band Imaging for Detection of Gastric Cancer Precursors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 3
- 主要终点
- Detection of Intestinal Metaplasia or Dysplasia
研究概览
简要总结
It is thought that the development of cancer of the stomach follows a series of stages in which the lining becomes increasingly abnormal. Early detection of precursors of gastric cancer likely enable less invasive treatment.
The assessment of gastric mucosa using the endoscope is used to detect cancers and these precursor lesions. Narrow band imaging uses filtered light already built into modern endoscopoes to identify the early changes in the gastric lining.
The investigators' hypothesis is that narrow band imaging improves detection of precursor lesions and is a method amenable to international standardization.
The investigators will conduct a prospective trial in which standard random biopsy, white light guided biopsy, and narrow band imaging guided biopsy will be performed for each patient. The yield of the different methods for gastric cancer precursors will thus be compared.
详细描述
1 BACKGROUND
Precursor Lesions
Gastric cancer is the fourth most common cancer and second leading cause of malignant death in the world. It often presents only with vague symptoms of dyspepsia and consequently is frequently diagnosed at advanced stages.
Gastric cancer develop in a series of steps beginning with H. pylori infection. 2-4 It induces an inflammatory reaction with the surrounding gut epithelium which is theorized to drive a subsequent progression in some patients to mucosal atrophy, intestinal metaplasia, dysplasia, and finally gastric adenonocarcinoma.
Systematic biopsy protocols
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •presenting for upper endoscopy for gastric indications
- •gastric indications include upper abdominal pain dyspepsia abnormal gastric imaging iron deficiency anemia gastric ulcer management of GI blood loss without active bleeding reflux weight loss.
排除标准
- •Subjects who are incarcerated, younger than 18, or unable to give informed consent will be excluded.
- •Patients who have evidence of active gastrointestinal bleeding will be excluded
- •Patients taking anti-thrombotic agents including clopidogrel, ticlopidine, coumadin, heparin, enoxaparin, and direct II or Xa inhibitors
- •Patients with INR >1.5, platelet count <75,000
结局指标
主要结局
Detection of Intestinal Metaplasia or Dysplasia
时间窗: One Year
Confirmation of intestinal metaplasia in stomach per patient by each method-NBI versus white light-versus random
次要结局
- Number of Regions with Intestinal Metaplasia(1 year)
- Number of regions with dysplasia(one year)
- Biopsies driven by method(One year)
- Helicobacter pyrlori detection(One year)
研究者
James Buxbaum
Assistant Professor
University of Southern California