PB has received educational grants from AbbVie, Janssen; speaker fees from AbbVie, Takeda; and advisory board fees from Hospira, Janssen, MSD, ...
Automated digital calculation of endoscopic and histological inflammation in ulcerative colitis: results of the Red Density study. P. BOSSUYT1,2 , H. NAKASE3, S. VERMEIRE1, H. WILLEKENS1, Y. IKEMOTO 4, T. MAKINO 4, R. BISSCHOPS1 1University Hospitals Leuven, Department of Gastroenterology, Leuven, Belgium 2 Imelda GI Clinical Research Centre, Department of Gastroenterology, Bonheiden, Belgium 3 Sapporo Medical University, Department of gastroenterology, Sapporo, Japan 4 Pentax Medical, Product development department, Tokyo, Japan
Conflicts of interest • •
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PB has received educational grants from AbbVie, Janssen; speaker fees from AbbVie, Takeda; and advisory board fees from Hospira, Janssen, MSD, Mundipharma, Roche, Pfizer, Takeda and Dr Falk Benelux. HN has received advisory fee from Kyorin Pharmaceutical CO.,Ltd., Mochida Pharmaceutical CO.,Ltd., Janssen Pharmaceutical K.K., Ffizer Lnc., honoraria from Tanabe Pharmaceutical CO.,Ltd., Astellas Pharmaceutical CO.,Ltd., Abbvie Inc., EA Pharma CO.,Ltd., Kyorin Pharmaceutical CO.,Ltd., Zeria Pharmaceutical CO.,Ltd., Mochida Pharmaceutical CO.,Ltd., Takeda Pharmaceutical CO.,Ltd., Janssen Pharmaceutical K.K., grants for commissioned/joint research from Hoya group Pentax Medical, Boehringer Ingelheim GmbH, Bristol-Myers Squibb Company. SV has received grant support from AbbVie, MSD, Pfizer and Takeda; received speaker fees from AbbVie, MSD, Takeda, Ferring, Dr. Falk Pharma, Hospira, Pfizer Inc and Tillots; and served as a consultant for AbbVie, MSD, Takeda, Ferring, Genentech/Roche, Shire, Pfizer Inc, Galapagos, Mundipharma, Hospira, Celgene, Second Genome, and Janssen. HW has no COI to declare. YI and TM are employees of Pentax medical. RB has received research support, consultancy and speaker's fee from Pentax medical. 2
Introduction The implementation of a treat-to-target algorithm in UC requires a robust objective target. 1 high inter-observer variability MAYO endoscopic subscore (MES) or ulcerative colitis endoscopic index of severity (UCEIS). 2,3
No consensus exists on the exact definition of mucosal healing in UC.4
Histological inflammation is predictive for relapse in UC in patients with endoscopic remission.5
An operator-independent endoscopic tool that correlates with histological inflammation would improve therapeutic decisions in UC. 1 Bossuyt et al. Curr Treat Options Gastroenterol. 2016 Mar;14(1):61-72. 2 Daperno et al. Dig Liver Dis. 2014 Nov;46(11):969-73. 3 Travis et al. Gut. 2012 Apr;61(4):535-42.
4 Vuitton et al. Aliment Pharmacol Ther. 2017 Mar;45(6):801-813. 5 Christensen et al. Clin Gastroenterol Hepatol. 2017 Oct;15(10):1557-1564.
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Aim • We aimed to develop an objective real time digital endoscopic tool for the evaluation of UC that correlates with histology.
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Methods •
The Red Density (RD) score (Pentax Medical) is an endoscopic score for the severity of the inflammation in UC that is calculated by an algorithm based on automated digital extraction of pixel data from white light (WL) endoscopic images before enhancement.
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A Pentax prototype endoscopy system including processor.
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Methods •
RD provides a continuous numeric scale from 0 to 255.
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Methods
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Methods: data collection • • • •
Sequential patients with UC and planned endoscopy in UZ Leuven Belgium and Sapporo Medical University Japan were included. WL and RD images were collected according to a standardized protocol. WL images were evaluated at random for MES and UCEIS by 2 blinded central readers. Final consensus was obtained in case of discordance. Standardized biopsies for Geboes and Robarts Histological Index (RHI) were taken in the most inflamed area of the images.
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Methods: refinement of the RD algorithm • The algorithm was refined by recalculating the RD score in a simulator in different steps: 1.
The range of the RD was adapted to have a better differentiation between the diverse degrees of RD. • Data with the high score in default range are greatly increased in revised range. • Images with distinct vascular pattern also increased there score in revised range.
2. 3.
Scored vascular pattern by vascular pattern recognition algorithm. Integration of the vascular score and the conventional RD score to make the final RD score. 9
Methods: refinement of the RD algorithm
Range adapted RD
RD score
Final RD score Vascular pattern recognition
Vascular score
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Results: data collection • In total 46 patients providing 100 images were included. • RD score was stable and reproducible in the same patient.
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Results: data collection
40
40
35
35
Number of pictures
Number of pictures
• There was an inter-observer agreement of κ =0.71 and κ=0.65 for the MES and UCEIS respectively after first central reading.
30 25 20 15 10
30 25 20 15 10 5
5
0
0
MAYO 0 MAYO 1 MAYO 2 MAYO 3
aggreement
discrepancy
UCEIS UCEIS UCEIS UCEIS UCEIS UCEIS 0 1 2 3 4 5 aggreement
discrepancy
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Results: correlation testing • RD showed a moderate correlation with the final consensus MES (r=0.58; p
