The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) Images Interpretation in Gastric Intestinal Metaplasia(GIM)
试验速览
- 阶段
- 不适用
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The change of accuracy of pCLE images interpretation in GIM after each examination
研究概览
简要总结
The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) images interpretation in Gastric Intestinal Metaplasia (GIM)
Objective:
The aim of this study is to evaluate the learning curve of pCLE images interpretation in GIM.
Research design:
Blinded review of pCLE images for the diagnosis of GIM
Sample size:
Five beginner endoscopists will be assigned in this study to read approximately 80 videoclips
Data analysis:
ROC curve is analyzed by SPSS version 16.
Expected Benefit and Clinical Application Information on the learning curve for GIM interpretation from pCLE images in order to develop early gastric cancer detection
详细描述
Background and Rationale:
Gastric cancer remains the second leading cause of cancer related death in the world. The incidence and mortality rate is predominant in East Asia[1]. Usually, gastric cancer is asymptomatic in early stage; therefore, most patients are in the advanced stage and incurable at diagnosis. The pathogenesis of intestinal type gastric cancer is sequential and multistep pathway. Gastric intestinal metaplasia (GIM) is the precancerous lesion for intestinal type gastric cancer[2]. The strategies which can detect precancerous and/or early cancerous transformation are very beneficial because only early gastric cancer can potentially be cured by endoscopic treatment. Probe-based confocal laser endomicroscope or pCLE is useful for GIM detection with 94% in sensitivity[3]. However, this perfect sensitivity in pCLE interpretation is provided in only expertise. We still do not know how to be an expert in GIM interpretation. No study about learning curve in GIM interpretation by pCLE published
Observation and Measurement:
Collect the accuracy in GIM interpretation from pCLE reported in ROC curve
Methodology:
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First year fellow of gastroenterologist who never have the experienced in pCLE interpretation.
排除标准
- 未提供
结局指标
主要结局
The change of accuracy of pCLE images interpretation in GIM after each examination
时间窗: Baseline and every 2 weeks for 4 sessions
Percentage of accuracy changing in each examination
次要结局
未报告次要终点
研究者
Rapat Pittayanon, MD
Principle investigator
King Chulalongkorn Memorial Hospital