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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Bangkok, Thailand, 10330
- Rekruttering
- Rapat Pittayanon
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Ta kontakt med:
- Rapat Pittayanon, MD
- Telefonnummer: 66813132112
- E-post: rapat125@gmail.com
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Ta kontakt med:
- Nuttapaht Namjud, M.Sc
- Telefonnummer: 66894971957
- E-post: ampere_nut@hotmail.com
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Underetterforsker:
- Rungsun Rerknimitr, Professor
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Hovedetterforsker:
- Rapat Pittayanon, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- First year fellow of gastroenterologist who never have the experienced in pCLE interpretation.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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pCLE images
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The change of accuracy of pCLE images interpretation in GIM after each examination
Tidsramme: 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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Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Rungsun Rerknimitr, Professor, King Chulalongkorn Memorial Hospital
- Hovedetterforsker: Rapat Pittayanon, MD, King Chulalongkron Memorial Hospital
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RP001
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