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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Bangkok, Tailandia, 10330
- Reclutamiento
- Rapat Pittayanon
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Contacto:
- Rapat Pittayanon, MD
- Número de teléfono: 66813132112
- Correo electrónico: rapat125@gmail.com
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Contacto:
- Nuttapaht Namjud, M.Sc
- Número de teléfono: 66894971957
- Correo electrónico: ampere_nut@hotmail.com
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Sub-Investigador:
- Rungsun Rerknimitr, Professor
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Investigador principal:
- Rapat Pittayanon, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- First year fellow of gastroenterologist who never have the experienced in pCLE interpretation.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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pCLE images
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The change of accuracy of pCLE images interpretation in GIM after each examination
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Rungsun Rerknimitr, Professor, King Chulalongkorn Memorial Hospital
- Investigador principal: Rapat Pittayanon, MD, King Chulalongkron Memorial Hospital
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RP001
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