Clinical trial · Observational
Implementation of Optical Diagnosis for Diminutive Polyps Amongst Endoscopists: Training and Long-term Quality Assurance
Implementation of Optical Diagnosis for Diminutive Polyps Amongst Accredited Endoscopists for the Dutch Bowel Cancer Screening Program: Training and Long-term Quality Assurance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Polyps | — | UNRESOLVED | — |
| Colonoscopy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Feedback | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Endoscopists
- description
- Approximately 35 endoscopists whom are certified to perform colonoscopies on FIT-positive patients in the Dutch population screening program
- interventionNames
- Behavioral: Feedback
- label
- Colonoscopies
- description
- Colonoscopies on FIT-positive patients in the Dutch population screening program
- label
- Device
- description
- Olympus colonoscopes with Narrow Band Imaging
Primary outcomes (2)
- measure
- 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
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (9)
- BACKGROUNDIgnjatovic A, East JE, Suzuki N, Vance M, Guenther T, Saunders BP. Optical diagnosis of small colorectal polyps at routine colonoscopy (Detect InSpect ChAracterise Resect and Discard; DISCARD trial): a prospective cohort study. Lancet Oncol. 2009 Dec;10(12):1171-8. doi: 10.1016/S1470-2045(09)70329-8. Epub 2009 Nov 10. PMID 19910250
- BACKGROUNDKuiper T, Marsman WA, Jansen JM, van Soest EJ, Haan YC, Bakker GJ, Fockens P, Dekker E. Accuracy for optical diagnosis of small colorectal polyps in nonacademic settings. Clin Gastroenterol Hepatol. 2012 Sep;10(9):1016-20; quiz e79. doi: 10.1016/j.cgh.2012.05.004. Epub 2012 May 18. PMID 22609999
- BACKGROUNDRex DK, Kahi C, O'Brien M, Levin TR, Pohl H, Rastogi A, Burgart L, Imperiale T, Ladabaum U, Cohen J, Lieberman DA. The American Society for Gastrointestinal Endoscopy PIVI (Preservation and Incorporation of Valuable Endoscopic Innovations) on real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc. 2011 Mar;73(3):419-22. doi: 10.1016/j.gie.2011.01.023. PMID 21353837
- BACKGROUNDKaminski MF, Hassan C, Bisschops R, Pohl J, Pellise M, Dekker E, Ignjatovic-Wilson A, Hoffman A, Longcroft-Wheaton G, Heresbach D, Dumonceau JM, East JE. Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2014 May;46(5):435-49. doi: 10.1055/s-0034-1365348. Epub 2014 Mar 17. PMID 24639382
- BACKGROUNDWanders LK, East JE, Uitentuis SE, Leeflang MM, Dekker E. Diagnostic performance of narrowed spectrum endoscopy, autofluorescence imaging, and confocal laser endomicroscopy for optical diagnosis of colonic polyps: a meta-analysis. Lancet Oncol. 2013 Dec;14(13):1337-47. doi: 10.1016/S1470-2045(13)70509-6. Epub 2013 Nov 13. PMID 24239209
- BACKGROUNDKaltenbach T, Rex DK, Wilson A, Hewett DG, Sanduleanu S, Rastogi A, Wallace M, Soetikno R. Implementation of optical diagnosis for colorectal polyps: standardization of studies is needed. Clin Gastroenterol Hepatol. 2015 Jan;13(1):6-10.e1. doi: 10.1016/j.cgh.2014.10.009. No abstract available.