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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by King Chulalongkorn Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01491724
First received: December 5, 2011
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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


Condition
Gastric Intestinal Metaplasia

Study Type: Observational
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)

Further study details as provided by King Chulalongkorn Memorial Hospital:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 5
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)
Groups/Cohorts
pCLE images

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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

5 beginner endoscopists who never had the experience in pCLE

Criteria

Inclusion Criteria:

  • First year fellow of gastroenterologist who never have the experienced in pCLE interpretation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491724

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

Locations
Thailand
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
Investigators
Study Director: Rungsun Rerknimitr, Professor King Chulalongkorn Memorial Hospital
Principal Investigator: Rapat Pittayanon, MD King Chulalongkron Memorial Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Rapat Pittayanon, MD, Principle investigator, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier: NCT01491724     History of Changes
Other Study ID Numbers: RP001
Study First Received: December 5, 2011
Last Updated: December 14, 2011
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Metaplasia
Gastritis, Atrophic
Pathologic Processes
Gastritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on September 22, 2014