Trial Information

The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) Images Interpretation in Gastric Intestinal Metaplasia(GIM)

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.