HEP DART 2017, Kona, Hawaii

Transcription

1 HEP DART 2017, Kona, Hawaii Rong Yu 1, Ke Xu 1, Jing Li 1, Tong Sun 1, Shengjiang Zhang 2, Jinhua Shao 2, Jin Sun 2, Qiong He 3, Jianwen Luo 3, Cheng Wang 4, Yudong Wang 4, Jing Chen 4, Vanessa Wu 4, George Lau 4, 5 1. Health100, Shanghai, China. 2. Wuxi Hisky Technologies Co. Ltd, Beijing, China. 3. Department of Biomedical Engineering, TsingHua University, Beijing, China. 4. Humanity and Health Research, Hong Kong, Hong Kong SAR. 5. Gastroenterology & Hepatology, Humanity & Health Medical Centre, Hong Kong, Hong Kong SAR.

2 AGE ACTIVITY 20 s Poster presentation 30 s Oral Abstract Presentation 40 s Invited Lectures 50 s Named Lectureships 60 s 70 s 80 s Awards; Business class travel Diminished Invites; Occasional Chair** Review Poster Presentation**

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4 Patients (n) NAFLD fibrosis score FIB-4 index AST to platelet ratio index Variables or formula age (years) body-mass index (kg/m²) impaired fasting glucose / diabetes(yes=1, no=0) AST:ALT ratio platelet count ( 10 9 /L) 0 66 albumin (g/dl) (age [years] AST [U/L]) / (platelet count [10⁹/L] ALT [U/L]) AST (IU/L) / ULN / platelet count ( 10⁹/L) 100 Area under curve Cutoff PPV NPV % 77% % 98% < % 33% > % 98% 0 67 >1 27% 89% FibroTest Patented formula % 71% BARD score BMI 28 = 1; AST:ALT ratio 0.8 = 2; Diabetes = 1 NAFLD=non-alcoholic fatty liver disease. AST=aspartate aminotransferase. ALT=alanine aminotransferase. ULN=upper limit of normal. NA <2 NA 96% 1. Angulo P, Hui JM, Marchesini G, et al. Hepatology 2007; 45: Shah AG, Lydecker A, Murray K, Tetri BN, Contos MJ, Sanyal AJ. Clin Gastroenterol Hepatol 2009; 7: McPherson S, Stewart SF, Henderson E, Burt AD, Day CP. Gut 2010; 59: Ratziu V, Massard J, Charlotte F, et al. BMC Gastroenterol 2006; 6: Harrison, S. A., Oliver, D., Arnold, H. L., Gogia, S. & Neuschwander-Tetri, B. A. Gut 2008;57:

5 FibroScan Echosens, Paris, France Relies on the measurement of the velocity of a low-frequency (50 Hz) elastic shear wave propagating through the liver; that is, directly related to tissue stiffness (the stiffer the tissue the faster the shear wave propagates) Q: What are the advantages of Fibroscan testing? A: -Noninvasive test, easily used at the point of care; -No pain; -Faster, only takes 5-7 min averagely; -Less expensive than liver biopsy; -Clinician get report simultaneously, and can explain to patients at the point of care; -FDA approved device for non-invasive liver diagnosis. Q: Is it validated against liver biopsy, the gold standard? A: Etiology Histology score CHC METAVIR system AUROC for fibrosis Nezam H. Afdhal. Gastroenterology & Hepatology 2012; 9 Castera L. et al. Nat. Rev. Gastroenterol. Hepatol 2013; 10: AUROCs for cirrhosis NAFLD Brunt Kleiner Viral hepatitis

6 FibroTouch : A 3 rd generation transient elastography that integrates a two-dimensional (2D)-image guided system for precise positioning, has been available for clinical use in China since FibroTouch possesses independent intellectual property rights (Patent No.: ZL ). Patent for Liver fibrosis detection technology is valided by Beijing Supreme People s Court Final Verdict

7 Q: What are the advantage of FibroTouch testing? A: -Only one dynamic probe is needed; -Simultaneously measures liver stiffness and hepatic Steatosis; -Provides more efficient detection and the success rate is high, particularly among obese patients; -Calculation time of single measurement < 1s FibroTouch Wuxi Hisky Medical Technology Co Ltd, Beijing, China; Patent: PCT/CN2010/ Uses controlled low-frequency shear wave to vibrate the liver and tracks the shear wave propagation through the liver tissue by highfrequency signal. Q: Is it validated against liver biopsy, the gold standard? A: Etiology Histology score AUROC for S3 CHB PBC The guideline of prevention and treatment for chronic hepatitis B (S0-S4) Chinese Society of Hepatology, Chinese Medical Association; Chinese Society of Gastroenterology, Chinese Medical Association; Chinese Society of Infectious Diseases, Chinese Medical Association. Consensus on the diagnosis and management of primary biliary cirrhosis (cholangitis) (S1-S4) Wong LH, Grace. Clinical and Molecular Hepatology 2014;20: Yuan LC, Shao JH, He MN, et al. Chin J Hepatol. 2014:22 Wu N,et al. Chin J Hepatol. 2014: 30 Zhang YG, et al. Chin J Hepatol. 2016: 24 AUROC for S

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9 Pateitns studied Jan 2016 and Aug patients (mean age 51, male 60%, mean BMI 24) LSM was measured by both FibroTouch and FibroScan at the same time. Liver biospy was done in selected patients at the clinician discretion. Scoring was performed by at least two independent pathologist (according to Ludwig/CRN/Knodell system).

10 Student t-test, Spearman rank correlation analysis, concordance test and receiver operating characteristic (ROC) curve were used to compare the readings from both Transient Elastography. In patients with liver biopsy, readings from TE were compared with histological score by ROC. AUROC was used to determine the performance of each TE.

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12 FibroTouch FibroScan p value Proportion of reliable results 97.7%, defined as IQR > 33% 91.4%, defined as successful rate >=30% <0.001 The average time per test 111 s 258 s <0.001

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15 Patients with Liver biopsy n=24 Sex, male 9 (37.5) Age, years 48 (29-71) BMI 26.5 ( ) ALT (U/I) 50.5 (10-301) AST (U/L) 27.5 (13-147) HBsAg + 1 (4.2%) LSM by FT (n=24) 6.2 (4-14.4) LSM by FS (n=12) 6.7 ( ) Histological stage CRN (n=12) 0 3 (25) 1a 4 (33.33) 1c 1 (8.33) 2 2 (16.67) 4 2 (16.67) Ludwig/Knodell (n=12) 0 6 (50) 1 4 (33.33) (8.33) 4 1 (8.33) Advanced liver fibrosis >F2 Cirrhosis F4

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17 205, 631 subjects attended any of the MOH healthcare centre for general check up 26,185 subjects with reliable data aged between 18 and 75 With at least one missing data (n=178,900) Age younger than 18 or older than 75 (n=392) Unreliable LSM (n=32) Unreliable UAP (n=78) Unreliable biochemical results (n=44) Without liver fibrosis or mild liver fibrosis (n=25210) With advanced liver fibrosis (n=975)

18 100,0 90,2 87,5 83,7 79,6 85,4 75,0 % 50,0 25,0 7,5 9,4 11,5 1,6 2,1 3,1 4,1 2,7 0,6 0,8 1,2 1,8 1,0 0,1 0,2 0,5 0,6 0,4 0, Total Age group F0F1 (<=7.3) F2 ( ) F2F3 ( ) F3F4 ( ) F4 (>=17.5) 13,8 10,5

19 Advanced fibrosis with normal ALT Advanced fibrosis with normal ALT, HBsAg- N = 566 N=150 Male 408 (72.1) 124 (82.7) Age, years 52.5 (22-75) 52 (25-74) BMI>24 kg/m2 404 (71.4) 114 (76.0) n=404 n=114 Liver steatosis (UAP) ( ) ( ) Minimal (<240) 124 (30.7) 28 (24.6) Mild ( ) 99 (24.5) 31 (27.2) Moderate ( ) 86 (21.3) 22 (19.3) Severe (>=295) 95 (23.5) 33 (29) GGT>=50 84 (20.1) 25 (21.9) Impaired glucose (FBG>=6.1) 72 (17.8) 17 (14.9) Total Cholestrol> (39.1) 41 (36.0) HDL> (29.4) 31 (27.2) LDL< (15.1) 23 (20.2) Triglyceride> (46.3) 58 (50.9) HBsAg (28.2) + 13 (3.2) Unknown 277 (68.6) Continous variables are presented as median (range); Categorical variables are presented as number (percentage).

20 FibroTouch and FibroScan are highly correlated in Chinese population FibroTouch have a good performance to identify advanced liver firbosis FibroTouch could be a valid approach in screening the advanced liver fibrosis in general population

21 Ethics Science Quality