Implementation of Optical Diagnosis for Diminutive Polyps Amongst Endoscopists: Training and Long-term Quality Assurance (DISCOUNT2)
Implementation of Optical Diagnosis for Diminutive Polyps Amongst Accredited Endoscopists for the Dutch Bowel Cancer Screening Program: Training and Long-term Quality Assurance
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Alkmaar、オランダ
- Medisch Centrum Alkmaar
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Almere、オランダ
- Flevoziekenhuis
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Amstelveen、オランダ
- Amstelland Ziekenhuis
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Amsterdam、オランダ
- Onze Lieve Vrouwe Gasthuis
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Amsterdam、オランダ
- Slotervaart Ziekenhuis
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Amsterdam、オランダ
- Sint Lucas Andreas Ziekenhuis
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Amsterdam、オランダ
- Antonie van Leeuwenhoek Ziekenhuis
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Beverwijk、オランダ
- Rode Kruis Ziekenhuis
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Haarlem、オランダ
- Kennemer Gasthuis
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Hoofddorp、オランダ
- Spaarne Ziekenhuis
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Hoorn、オランダ
- West Fries Gasthuis
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Nieuwegein、オランダ
- Sint Antonius Ziekenhuis
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Utrecht、オランダ
- Diakonessenhuis
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Endoscopists
Approximately 35 endoscopists whom are certified to perform colonoscopies on FIT-positive patients in the Dutch population screening program
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3-monthly or no 3-monthly feedback on results of optical diagnosis
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Colonoscopies
Colonoscopies on FIT-positive patients in the Dutch population screening program
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Device
Olympus colonoscopes with Narrow Band Imaging
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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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
時間枠：18 months
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18 months
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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.
時間枠：18 months
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18 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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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
時間枠：18 months
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18 months
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the number of diminutive (1-5mm) and small (6-9mm) lesions that are correctly predicted with high confidence
時間枠：18 months
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18 months
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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
時間枠：18 months
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18 months
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the number of patients in whom the surveillance interval (according to the Dutch surveillance guideline) is correctly predicted based on endoscopic diagnosis
時間枠：18 months
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18 months
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the number of correctly diagnosed sessile serrated adenoma/polyps in diminutive (1-5mm) and small (6-9mm) polyps
時間枠：18 months
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18 months
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the sensitivity for predicting neoplastic histology per endoscopist, time frame and feedback or no feedback group
時間枠：18 months
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18 months
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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
時間枠：18 months
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18 months
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協力者と研究者
捜査官
- 主任研究者：Evelien Dekker, Prof. dr.、e.dekker@amc.uva.nl
出版物と役立つリンク
一般刊行物
- Ignjatovic 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.
- Rex 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.
- Kaminski 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.
- Hazewinkel Y, Lopez-Ceron M, East JE, Rastogi A, Pellise M, Nakajima T, van Eeden S, Tytgat KM, Fockens P, Dekker E. Endoscopic features of sessile serrated adenomas: validation by international experts using high-resolution white-light endoscopy and narrow-band imaging. Gastrointest Endosc. 2013 Jun;77(6):916-24. doi: 10.1016/j.gie.2012.12.018. Epub 2013 Feb 21.
- Kuiper 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.
- Wanders 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.
- Kaltenbach 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.
- Kumar S, Fioritto A, Mitani A, Desai M, Gunaratnam N, Ladabaum U. Optical biopsy of sessile serrated adenomas: do these lesions resemble hyperplastic polyps under narrow-band imaging? Gastrointest Endosc. 2013 Dec;78(6):902-909. doi: 10.1016/j.gie.2013.06.004. Epub 2013 Jul 9.
- Vleugels JLA, Hazewinkel Y, Dijkgraaf MGW, Koens L, Fockens P, Dekker E; DISCOUNT study group. Optical diagnosis expanded to small polyps: post-hoc analysis of diagnostic performance in a prospective multicenter study. Endoscopy. 2019 Mar;51(3):244-252. doi: 10.1055/a-0759-1605. Epub 2018 Dec 13.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- W14_099
- NTR4635 (レジストリ識別子：The Netherlands National Trial Register)
- FP 13 (その他の助成金/資金番号：Dutch Digestive Foundation)
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Feedbackの臨床試験
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Vanderbilt UniversityNational Institute of Mental Health (NIMH); Leon Lowenstein Foundation Inc.完了
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New York UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)募集
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