Experience and challenges of implementing optical diagnosis into clinical practice UK and European Perspective

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1 Experience and challenges of implementing optical diagnosis into clinical practice UK and European Perspective WEO Image Enhanced Endoscopy San Diego, USA Dr James East Consultant Gastroenterologist Honorary Senior Clinical Lecturer 20 th May 2016

2 Outline & Key Questions What are the challenges of implementing optical diagnosis into clinical practice? Accreditation and implementation processes Endoscopists What are alternatives to resect & discard? Sessile serrated polyps Community diagnostic performance DISCARD-lite (progressive adoption)?

3 Optical diagnosis vs pathology Detection FIRST East & Leedham. Endoscopy 2014;46:318-21

4 Lancet Oncology Meta-analysis: n=91 NBI n=56 iscan n=9 FICE n=14 NPV 82 5 (75 4 to 87 9) 86 5 (78 0 to 92 1) 83 7 (77 5 to 88 4) Wanders L et al. Lancet Oncology 2013;14:

5 ASGE 2016 Experts Kaminski MF et al. Endoscopy 2014;46: ASGE Technology Committee. GIE 2015;81:502

6 Industry online training and certificates Comany Accreditation slide Killer colon polyps left to save NHS cash

7 Community based NBI DISCARD? Ladabaum U et al. Gastro 2013;144:81 91 Rees CJ et al. Gut 2016 [In press]

8 National Int Patient consent to optical biopsy? CLINICAL: Gastroenterologist, Endoscopists, Pathologist, Nurse Endoscopists (x4) ECONOMICS: Healthcare economists (x2) NICE TEAM: Chair, project managers, admin, implementation group (x6) DG10004/documents/final-scope

9 DISCARD expert accreditation cycle Who can accredit? Training 1-2 years Reaccreditation Accreditation Audit?part web based

10 Should everyone perform optical biopsy? John Anderson, National Endoscopy Training Lead

11 NICE NBI classification Sano Y et al. Dig Endosc 2016 [In press]

12 NICE validation Hewett DG et al. Gastro 2012;143:

13 NICE with FICE Repici A et al. Gastrointest Endosc 2016 [In press]

14 ESGE Technological review on Advanced Endoscopic Imaging [due 2016] 1. We recommend the use of validated classification systems to support the use of optical diagnosis with advanced endoscopic imaging in the upper and lower GI tracts. (Strong recommendation, moderate quality evidence). 2. We suggest that training improves performance for the use of advanced endoscopic imaging techniques and that it is a pre-requisite for use in clinical practice. A learning curve exists and training alone does not guarantee sustained high performances in clinical practice (weak recommendation, low quality evidence).

15 Serrated pathway to CRC East & Dekker. Nat Rev Gastro Hep 2013;10:69-70

16 US Multi-society taskforce: Serrated lesions surveillance 2012 Lieberman D et al. Gastro 2012;143:844-57

17 Risk markers for future colorectal cancer Flexible sigmoidoscopy screening Holme Ø et al. Gut. 2015;64: Erichsen R et al. Gastro 2016;150:

18 WASP SSP classification NICE 2 WASP features IJspeert JE et al. Gut 2016;65:

19 WASP diagnostic performance IJspeert JE et al. Gut 2016;65:

20 Pragmatic DISCARD? WASP? Wang & East. Gastrointest Endosc 2015;82:

21 Risk advanced pathology polyps 5mm Study Cohort N Advanced pathology Hassan 2010 Kolligs 2012 Rutter [Unpublished] 4 x US screening Mixed German UK FOBT positive Cancer % 0.04% % 0.4% > % 0.11%

22 Risk advanced pathology polyps 5mm Study Cohort N Advanced pathology Hassan 2010 Kolligs 2012 Rutter [Unpublished] 4 x US screening Mixed German UK FOBT positive Cancer % 0.04% % 0.4% > % 0.11%

23 Risk advanced pathology polyps 5mm Study Cohort N Advanced pathology Hassan 2010 Kolligs 2012 Rutter [Unpublished] 4 x US screening Mixed German UK FOBT positive Cancer % 0.04% % 0.4% > % 0.11%

24 ...diminutive polyps in the rectosigmoid only, the NPV for diagnosing adenomatous histology with NBI was 95% - Gupta N et al. GIE 2012;75:

25 DISCARD LITE 1. Proximal to rectosigmoid junction: all polyp are assumed premalignant, resect and discard 2. Distal to rectosigmoid: DISCARD strategy as per PIVI, hyperplastic polyps left in situ 3. Surveillance interval calculation (DISCARD-lite): all proximal polyps + distal polyps characterized as adenomas Interval = equivalent number adenomas Atkinson & East. GIE 2015;82:

26 Key messages from UK & Europe Current recommendations ESGE / AGSE not sufficient Unclear definition experienced / expert Community based data conflicting Need for training, accreditation, audit and reaccreditation Likely highly cost effective - pressure to use? ESGE technology review: Validated scales for each technology Training Sessile serrated polyps potentially problematic Consider progressive implementation DISCARD-lite

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