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Implementation of Optical Diagnosis for Diminutive Polyps Amongst Endoscopists: Training and Long-term Quality Assurance (DISCOUNT2)

8. januar 2018 oppdatert av: Prof. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Implementation of Optical Diagnosis for Diminutive Polyps Amongst Accredited Endoscopists for the Dutch Bowel Cancer Screening Program: Training and Long-term Quality Assurance

In this study, Dutch gastroenterologists who are certified for performing colonoscopies on FIT-positive patients in the Dutch population screening program are trained in optical diagnosis with validated methods. After this training, an ex- and in-vivo test phase leads to "accreditation" and endoscopists will be observed in their optical diagnosis for 1 year. During this year, half of the endoscopists will be randomized towards 3-monthly feedback and the other half will receive feedback on their results after 1 year. The endoscopic prediction of endoscopists on polyp histology will be compared to histopathological outcome.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Through the recently started nationwide bowel cancer screening programme in the Netherlands, an extra 70.000 colonoscopies are annually performed. In current practice, all resected colonic lesions are histopathologically analysed. Even diminutive polyps, which rarely harbour cancer or advanced histological features. If endoscopists are able to accurately differentiate between neoplastic and non-neoplastic lesions during colonoscopy, practice could become more efficient and costeffective. This strategy is called optical diagnosis and two clinical practice strategies have been proposed by the American Society of Gastroenterologists (ASGE). First, diminutive polyps could be resected and discarded if >90% of the surveillance intervals predicted on optical diagnosis correlate with the surveillance intervals after histopathological validation (if assessed with high confidence). Second, hyperplastic polyps in the rectosigmoid could be left in situ if endoscopists are able to confidently predict neoplastic histology of diminutive colorectal polyps with a negative predictive value (NPV) of ≥90%.

The accuracy of white light colonoscopy is not acceptable for daily practice (59%-84%), but narrow band imaging (NBI) allows higher accuracies up to 98% and it was demonstrated that experienced endoscopists could reach a NPV of ≥90% for diminutive colorectal lesions. However, recent research shows that community gastroenterologists are not able to meet the quality thresholds proposed by the ASGE. Before this strategy could be safely applied in daily practice, community gastroenterologists should be able to meet thresholds as well.

In this study, Dutch gastroenterologists who are certified for performing colonoscopies on FIT-positive patients in the Dutch population screening program, are trained in optical diagnosis with validated methods. After training, an ex- and in-vivo test phase leads to "accreditation" and endoscopists will be observed in their optical diagnosis for 1 year. During this year, half of the endoscopists will be randomized towards 3-monthly feedback and the other half will receive feedback on their results after 1 year. The endoscopic prediction of endoscopists on polyp histology will be compared to histopathological outcome.

Studietype

Observasjonsmessig

Registrering (Faktiske)

3144

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Nederland
      • Alkmaar, Nederland
        • Medisch Centrum Alkmaar
      • Almere, Nederland
        • Flevoziekenhuis
      • Amstelveen, Nederland
        • Amstelland Ziekenhuis
      • Amsterdam, Nederland
        • Onze Lieve Vrouwe Gasthuis
      • Amsterdam, Nederland
        • Slotervaart Ziekenhuis
      • Amsterdam, Nederland
        • Sint Lucas Andreas Ziekenhuis
      • Amsterdam, Nederland
        • Antonie van Leeuwenhoek Ziekenhuis
      • Beverwijk, Nederland
        • Rode Kruis Ziekenhuis
      • Haarlem, Nederland
        • Kennemer Gasthuis
      • Hoofddorp, Nederland
        • Spaarne Ziekenhuis
      • Hoorn, Nederland
        • West Fries Gasthuis
      • Nieuwegein, Nederland
        • Sint Antonius Ziekenhuis
      • Utrecht, Nederland
        • Diakonessenhuis

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

55 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Endoscopists certified for performing Dutch screening colonoscopies. Colonoscopies in patients performed after a positive FIT obtained for the Dutch colorectal cancer screening program.

Beskrivelse

Inclusion Criteria:

  • Colonoscopies performed in FIT positive patients obtained for the Dutch colorectal cancer screening program.

Exclusion Criteria:

  • Colonoscopies in patients with a history of colorectal cancer, inflammatory bowel disease or polyposis syndrome.
  • Colonoscopies in patients with bleeding disorders or anticoagulants and therefore cannot undergo polypectomy.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Endoscopists
Approximately 35 endoscopists whom are certified to perform colonoscopies on FIT-positive patients in the Dutch population screening program
Atferdsmessig: Feedback
3-monthly or no 3-monthly feedback on results of optical diagnosis
Colonoscopies
Colonoscopies on FIT-positive patients in the Dutch population screening program
Device
Olympus colonoscopes with Narrow Band Imaging

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
the number of training rounds needed until endoscopists reach a clinical acceptable accuracy of predicting histology of subcentimetric (1-9 mm) colorectal lesions using NBI
Tidsramme: 18 months
18 months
the number of qualified endoscopists that are able to maintain a clinical acceptable accuracy of predicting histology of subcentimetric (1-9 mm) colorectal lesions using NBI over a year, either with and without regular interim feedback.
Tidsramme: 18 months
18 months

Sekundære resultatmål

Resultatmål
Tidsramme
the number of the accredited endoscopists that is able to reach a negative predictive value of at least 90% for predicting neoplastic diminutive (1-5mm) and small (6-9mm) colorectal lesions in the rectosigmoid
Tidsramme: 18 months
18 months
the number of diminutive (1-5mm) and small (6-9mm) lesions that are correctly predicted with high confidence
Tidsramme: 18 months
18 months
the number of patients in whom a surveillance interval (according to the Dutch surveillance guideline) can be advised directly after colonoscopy, based on the endoscopic diagnosis
Tidsramme: 18 months
18 months
the number of patients in whom the surveillance interval (according to the Dutch surveillance guideline) is correctly predicted based on endoscopic diagnosis
Tidsramme: 18 months
18 months
the number of correctly diagnosed sessile serrated adenoma/polyps in diminutive (1-5mm) and small (6-9mm) polyps
Tidsramme: 18 months
18 months
the sensitivity for predicting neoplastic histology per endoscopist, time frame and feedback or no feedback group
Tidsramme: 18 months
18 months
the costs in euros that would have been saved by multiplying the amount of high confidence predicted diminutive and small polyps with the histopathology costs per lesion
Tidsramme: 18 months
18 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Samarbeidspartnere

Dutch Digestive Diseases Foundation

Etterforskere

  • Hovedetterforsker: Evelien Dekker, Prof. dr., e.dekker@amc.uva.nl

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2015

Primær fullføring (Faktiske)

28. februar 2017

Studiet fullført (Faktiske)

1. januar 2018

Datoer for studieregistrering

Først innsendt

19. mars 2015

Først innsendt som oppfylte QC-kriteriene

31. mars 2015

Først lagt ut (Anslag)

3. april 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. januar 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. januar 2018

Sist bekreftet

1. januar 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • W14_099
  • NTR4635 (Registeridentifikator: The Netherlands National Trial Register)
  • FP 13 (Annet stipend/finansieringsnummer: Dutch Digestive Foundation)

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