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

8 januari 2018 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

3144

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

55 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Endoscopists
Approximately 35 endoscopists whom are certified to perform colonoscopies on FIT-positive patients in the Dutch population screening program
Beteende: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
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
Tidsram: 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.
Tidsram: 18 months
18 months

Sekundära resultatmått

Resultatmått
Tidsram
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
Tidsram: 18 months
18 months
the number of diminutive (1-5mm) and small (6-9mm) lesions that are correctly predicted with high confidence
Tidsram: 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
Tidsram: 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
Tidsram: 18 months
18 months
the number of correctly diagnosed sessile serrated adenoma/polyps in diminutive (1-5mm) and small (6-9mm) polyps
Tidsram: 18 months
18 months
the sensitivity for predicting neoplastic histology per endoscopist, time frame and feedback or no feedback group
Tidsram: 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
Tidsram: 18 months
18 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

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

Samarbetspartners

Dutch Digestive Diseases Foundation

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2015

Primärt slutförande (Faktisk)

28 februari 2017

Avslutad studie (Faktisk)

1 januari 2018

Studieregistreringsdatum

Först inskickad

19 mars 2015

Först inskickad som uppfyllde QC-kriterierna

31 mars 2015

Första postat (Uppskatta)

3 april 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 januari 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 januari 2018

Senast verifierad

1 januari 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • W14_099
  • NTR4635 (Registeridentifierare: The Netherlands National Trial Register)
  • FP 13 (Annat bidrag/finansieringsnummer: Dutch Digestive Foundation)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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