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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

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

Brief Summary:

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


Detailed Summary:

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 r
    Sponsor: King Chulalongkorn Memorial Hospital

    Current Primary Outcome: The change of accuracy of pCLE images interpretation in GIM after each examination [ Time Frame: Baseline and every 2 weeks for 4 sessions ]

    Percentage of accuracy changing in each examination


    Original Primary Outcome: The change of accuracy of pCLE images interpretation in GIM after each examination [ Time Frame: up to 5 months ]

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: King Chulalongkorn Memorial Hospital

    Dates:
    Date Received: December 5, 2011
    Date Started: September 2011
    Date Completion: April 2012
    Last Updated: December 14, 2011
    Last Verified: December 2011