Implementation of Optical Diagnosis for Diminutive Polyps Amongst Endoscopists: Training and Long-term Quality Assurance
- Conditions
- ColonoscopyColonic Polyps
- Interventions
- Behavioral: Feedback
- Registration Number
- NCT02407925
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3144
- Colonoscopies performed in FIT positive patients obtained for the Dutch colorectal cancer screening program.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Endoscopists Feedback Approximately 35 endoscopists whom are certified to perform colonoscopies on FIT-positive patients in the Dutch population screening program
- Primary Outcome Measures
Name Time Method 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 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. 18 months
- Secondary Outcome Measures
Name Time Method 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 18 months the sensitivity for predicting neoplastic histology per endoscopist, time frame and feedback or no feedback group 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 18 months 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 18 months the number of diminutive (1-5mm) and small (6-9mm) lesions that are correctly predicted with high confidence 18 months the number of patients in whom the surveillance interval (according to the Dutch surveillance guideline) is correctly predicted based on endoscopic diagnosis 18 months the number of correctly diagnosed sessile serrated adenoma/polyps in diminutive (1-5mm) and small (6-9mm) polyps 18 months
Trial Locations
- Locations (13)
Antonie van Leeuwenhoek Ziekenhuis
🇳🇱Amsterdam, Netherlands
Sint Lucas Andreas Ziekenhuis
🇳🇱Amsterdam, Netherlands
Rode Kruis Ziekenhuis
🇳🇱Beverwijk, Netherlands
Diakonessenhuis
🇳🇱Utrecht, Netherlands
Medisch Centrum Alkmaar
🇳🇱Alkmaar, Netherlands
Flevoziekenhuis
🇳🇱Almere, Netherlands
Amstelland Ziekenhuis
🇳🇱Amstelveen, Netherlands
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Slotervaart Ziekenhuis
🇳🇱Amsterdam, Netherlands
Sint Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Kennemer Gasthuis
🇳🇱Haarlem, Netherlands
Spaarne Ziekenhuis
🇳🇱Hoofddorp, Netherlands
West Fries Gasthuis
🇳🇱Hoorn, Netherlands