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Implementation of optical diagnosis for diminutive polyps amongst accredited endoscopists for the Dutch bowel cancer screening program: training and long-term quality assurance.


- candidate number18036
- NTR NumberNTR4635
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-jun-2014
- Secondary IDsMLDS: FP-13 METC AMC: W14_099
- Public TitleImplementation of optical diagnosis for diminutive polyps amongst accredited endoscopists for the Dutch bowel cancer screening program: training and long-term quality assurance.
- Scientific TitleImplementation of optical diagnosis for diminutive polyps amongst accredited endoscopists for the Dutch bowel cancer screening program: training and long-term quality assurance.
- ACRONYMDISCOUNT II
- hypothesis1) Whether endoscopists are able to learn optical diagnosis of colonic polyps using NBI by a validated training and feedback program
2) Whether these endoscopists are able to reach the threshold provided by the PIVI guidelines for predicting the diagnosis of diminutive lesions
3) Whether regular measurement and feedback of optical diagnosis will be needed to assure the quality of this optical diagnosis strategy.
- Healt Condition(s) or Problem(s) studiedPolyps, Coloscopy, Early diagnostics
- Inclusion criteriaPatients: all those with polyps who receive a coloscopy in the context of the Dutch bowel cancer screening program

Endoscopists: all those who are accredited to perform colonoscopies for the nationwide Dutch bowel colorectal cancer screening program
- Exclusion criteriaPatients with inflammatory bowel disease. Patients who had a CRC before.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2015
- planned closingdate1-okt-2016
- Target number of participants30
- InterventionsValidated training, qualification and 3-monthly feedback
- Primary outcomePrimary aims
1) Number of training rounds needed to reach clinically acceptable prediction of histology (accuracy > 90%) for colorectal lesions
2) To assess whether qualified endoscopists are able to maintain this performance over a year, and if feedback is of additional value
- Secondary outcomeSecondary aims:
1) number of endoscopists reaching NPV > 90% for predicting neoplastic histology in continuation phase
2) number of correctly advised surveillance intervals
3) number of correctly predicted diminutive (1-5mm) lesions
4) number of surveillance intervals predicted on endoscopic diagnosis
5) number of correctly diagnosed small (6-9mm) lesions
6) budget impact analysis
- Timepoints- 3-monthly feedback with up-to-date accuracy, negative predictive value, sensitivity and specificity on optical diagnosis of diminutive (1-5mm) and small (6-9mm) polyps.
- Overview of NICE/WASP/KUDO optical diagnosis principles
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD, PhD Evelien Dekker
- CONTACT for SCIENTIFIC QUERIESMD, PhD Evelien Dekker
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Dutch Digestive Diseases Foundation
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD5-jun-2014 - 23-jan-2015


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