Gastric Intestinal Metaplasia Clinical Trial
Official title:
The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) Images Interpretation in Gastric Intestinal Metaplasia(GIM)
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
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:
1. Six inexperienced pCLE readers were recruited.
2. All inexperienced pCLE readers must attend the learning session.
3. Self-review from CD is recommended for all inexperienced pCLE readers
4. Two-week interval for examination in GIM interpretation from 20 new histology-proved
pCLE images (GIM and normal mucosa) for 5 sessions are on schedule after training
session.
5. All Inexperienced pCLE readers need to review the training CD at least a day before each
examination.
6. The accuracy rate in each examination will be recorded individually for each
inexperienced pCLE reader.
7. ROC curve is reported for learning curve in GIM interpretation from pCLE images.
Data collection:
All data will be processed and recorded by one physician.
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