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

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ClinicalTrials.gov Identifier: NCT01491724
Recruitment Status : Unknown
Verified December 2011 by Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : December 14, 2011
Last Update Posted : December 15, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

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

Condition or disease
Gastric Intestinal Metaplasia

Detailed Description:

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


  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.

Study Design

Study Type : Observational
Estimated Enrollment : 5 participants
Time Perspective: Cross-Sectional
Official Title: The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) Images Interpretation in Gastric Intestinal Metaplasia(GIM)
Study Start Date : September 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : April 2012
Groups and Cohorts

pCLE images

Outcome Measures

Primary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
5 beginner endoscopists who never had the experience in pCLE

Inclusion Criteria:

  • First year fellow of gastroenterologist who never have the experienced in pCLE interpretation.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491724

Contact: Rapat Pittayanon, MD 66813132112 Rapat125@gmail.com
Contact: Nuttaphat Namjud, M.Sc. 66894971957 ampere_nut@hotmail.com

Rapat Pittayanon Recruiting
Bangkok, Thailand, 10330
Contact: Rapat Pittayanon, MD    66813132112    rapat125@gmail.com   
Contact: Nuttapaht Namjud, M.Sc    66894971957    ampere_nut@hotmail.com   
Sub-Investigator: Rungsun Rerknimitr, Professor         
Principal Investigator: Rapat Pittayanon, MD         
Sponsors and Collaborators
King Chulalongkorn Memorial Hospital
Study Director: Rungsun Rerknimitr, Professor King Chulalongkorn Memorial Hospital
Principal Investigator: Rapat Pittayanon, MD King Chulalongkron Memorial Hospital
More Information

Additional Information:
Responsible Party: Rapat Pittayanon, MD, Principle investigator, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier: NCT01491724     History of Changes
Other Study ID Numbers: RP001
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: December 15, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Pathologic Processes