The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) Images Interpretation in Gastric Intestinal Metaplasia (GIM)
The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) Images Interpretation in Gastric Intestinal Metaplasia(GIM)
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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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:
- 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.
Data collection:
All data will be processed and recorded by one physician.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Bangkok, Thaïlande, 10330
- Recrutement
- Rapat Pittayanon
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Contact:
- Rapat Pittayanon, MD
- Numéro de téléphone: 66813132112
- E-mail: rapat125@gmail.com
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Contact:
- Nuttapaht Namjud, M.Sc
- Numéro de téléphone: 66894971957
- E-mail: ampere_nut@hotmail.com
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Sous-enquêteur:
- Rungsun Rerknimitr, Professor
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Chercheur principal:
- Rapat Pittayanon, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- First year fellow of gastroenterologist who never have the experienced in pCLE interpretation.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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pCLE images
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The change of accuracy of pCLE images interpretation in GIM after each examination
Délai: Baseline and every 2 weeks for 4 sessions
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Percentage of accuracy changing in each examination
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Baseline and every 2 weeks for 4 sessions
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Rungsun Rerknimitr, Professor, King Chulalongkorn Memorial Hospital
- Chercheur principal: Rapat Pittayanon, MD, King Chulalongkron Memorial Hospital
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RP001
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