The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) Images Interpretation in Gastric Intestinal Metaplasia (GIM)
Recruitment status was Recruiting
The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) images interpretation in Gastric Intestinal Metaplasia (GIM)
The aim of this study is to evaluate the learning curve of pCLE images interpretation in GIM.
Blinded review of pCLE images for the diagnosis of GIM
Five beginner endoscopists will be assigned in this study to read approximately 80 videoclips
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
Gastric Intestinal Metaplasia
|Study Design:||Time Perspective: Cross-Sectional|
|Official Title:||The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) Images Interpretation in Gastric Intestinal Metaplasia(GIM)|
- The change of accuracy of pCLE images interpretation in GIM after each examination [ Time Frame: Baseline and every 2 weeks for 4 sessions ] [ Designated as safety issue: Yes ]Percentage of accuracy changing in each examination
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||April 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
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. 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. 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. 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
- Six inexperienced pCLE readers were recruited.
- All inexperienced pCLE readers must attend the learning session.
- Self-review from CD is recommended for all inexperienced pCLE readers
- 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.
- All Inexperienced pCLE readers need to review the training CD at least a day before each examination.
- The accuracy rate in each examination will be recorded individually for each inexperienced pCLE reader.
- ROC curve is reported for learning curve in GIM interpretation from pCLE images.
All data will be processed and recorded by one physician.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491724
|Contact: Rapat Pittayanon, MD||66813132112||Rapat125@gmail.com|
|Contact: Nuttaphat Namjud, M.Sc.||firstname.lastname@example.org|
|Bangkok, Thailand, 10330|
|Contact: Rapat Pittayanon, MD 66813132112 email@example.com|
|Contact: Nuttapaht Namjud, M.Sc 66894971957 firstname.lastname@example.org|
|Sub-Investigator: Rungsun Rerknimitr, Professor|
|Principal Investigator: Rapat Pittayanon, MD|
|Study Director:||Rungsun Rerknimitr, Professor||King Chulalongkorn Memorial Hospital|
|Principal Investigator:||Rapat Pittayanon, MD||King Chulalongkron Memorial Hospital|