肝纖維化掃描培訓(xùn)

1、User Training使用者培訓(xùn)FS 502 Step 5軟件版本A 2.007/2011,Legal information法律信息,Legal information,,3,[UTS FibroScan® 502.3] - Revision date [15/07/2012] - FibroScan® 502 is a class IIa medical device according to D

2、irective EC/93/42 and is manufactured by Echosens. Assessment of its conformity with the essential requirements of the Directive EC/93/42 is established by the LNE-G-MED (France). FibroScan® is indicated for the non

3、 invasive measurement of liver stiffness (E) [and controlled attenuation parameter (CAP)] in human beings.It is expressly recommended to closely read the instruction of the users’ guide and labeling of the device. Fibro

4、Scan® examination must be performed only by operator certified by the manufacturer or its accredited local representative. FibroScan® must not be used in the following situation: other organs but liver, patient

5、s with active implantable medical devices (such as pacemaker, defibrillators, pump, etc.), wound at the measurement point, pregnant women. Presence of ascites can prevent from obtaining valid measurements. The values obt

6、ained with FibroScan® must be interpreted by a physician experienced in dealing with liver disease, taking into account the complete medical record of the patients.In France, liver stiffness measurement by FibroSca

7、n® is included on the list of acts and services covered by the national Social Security medical insurance under the code HLQM002 and the following conditions. [UTS FibroScan® 502.3] - Revision date [15/07/201

8、2] – 根據(jù)EC/93/42法規(guī)，F(xiàn)ibroScan® 502是IIa類醫(yī)療器械，由Echosens公司生產(chǎn)。LNE-G-MED (法國)評估確認(rèn)了其符合EC/93/42法規(guī)。Fibroscan是用來對人類進(jìn)行肝臟硬度的無創(chuàng)測量【和控制衰減參數(shù)】（CAP）。強(qiáng)烈推薦詳細(xì)閱讀該設(shè)備的使用說明書和標(biāo)貼。Fibroscan檢查必須由制造商或其授權(quán)的當(dāng)?shù)卮眍C發(fā)證書的操作者進(jìn)行操作。Fibroscan在以下情況不能使用：肝臟以外的器

9、官、移植有其他活性的醫(yī)療器械的患者（例如起搏器、除顫器、泵及其他）、測量點(diǎn)有傷口、孕婦。腹水會影響測量的準(zhǔn)確性。Fibroscan的測量值必須由對肝臟疾病有經(jīng)驗(yàn)的醫(yī)師來解讀，并參考該患者完整的醫(yī)療記錄。在法國，F(xiàn)ibroscan所進(jìn)行的肝臟硬度測量項(xiàng)目被列入國家社會安全醫(yī)療保險(xiǎn)所涵蓋的醫(yī)療服務(wù)中（ code HLQM002 ） 并要求符合以下條件。,Legal information法律信息,,Indications: (i) asse

10、ssment of chronic untreated hepatitis C adult patients with no comorbidities except obvious diagnosis of cirrhosis or (ii) assessment of chronic untreated hepatitis C adult patients with HIV coinfection except obvious di

11、agnosis of cirrhosis. 適應(yīng)癥：1.用于排除有明顯肝硬化診斷之外無其他并發(fā)疾病的未治療的慢性丙肝成年患者的評估；2.用于排除有明顯肝硬化診斷之外的合并HIV的未治療的慢性丙型肝炎成年患者的評估。Invoicing note: Within the limit of one examination per year except in case of risk factors of rapid evolution

12、toward cirrhosis, if this new examination is expected to have an impact on the therapeutic management of the patient. In case of chronic hepatitis C: (i) as first line test as an alternative to blood tests (ii) as second

13、 line test (in case of non agreement between the first line test and the clinical context or in case of non interpretable first line test) as an alternative to liver biopsy. In case of HIV-HCV coinfection: as first line

14、test to evaluate the presence of cirrhosis. 報(bào)銷要求：如果新的檢查是用來對患者進(jìn)行治療管理，并限制在每年行一次檢查（并成正朝著肝硬化快速進(jìn)展的除外）。對于慢性丙肝：1.作為替代血液實(shí)驗(yàn)的首選；2.作為替代肝活檢的二線檢測（在首選檢測和臨床病史不符合的情況下或在首選試驗(yàn)無法確診的情況下）。對于HIV-HCV合并感染的患者，作為診斷肝硬化的首選方法。Environment: consultat

15、ion specialized in the management of patients with HCV, in collaboration with a center specialized in the management of the HIV infection for the second indication. 環(huán)境：精通于HCV管理的咨詢會診，對于第二適應(yīng)癥與精通于HIV感染管理的醫(yī)生合作,07/2011,,4,Tr

16、aining Warning 培訓(xùn)警告,07/2011,,5,Warning,The aim of this training is to teach you how to perform good quality and reliable measurements in an efficient way.本次培訓(xùn)的目的是教會大家如何使用正確的方法執(zhí)行精確、有效測量。Only operators who complete this

17、whole training will be certified to use the FibroScan®.操作者必須經(jīng)過完整的培訓(xùn)才有資格使用FibroScan® ®.,The training consists of two parts: 培訓(xùn)由兩部分組成：A slide presentation幻燈片演示A practice session: 練習(xí),07/2011,,6,Introductio

18、n簡介Elastography principle彈性成像原理Stiffness measurement principle硬度測定原理CAP measurement principle CAP測定原理Presentation of the device 設(shè)備介紹Select and launch an examination選擇并啟動檢查Patient examination患者測定Safety recom

19、mendations安全建議Probe disinfection and calibration探頭消毒和校準(zhǔn),Introduction簡介,Introduction (1)介紹,,8,Introduction,Chronic liver diseases lead to fibrosis and then to cirrhosis and its potential complications.慢性肝病會導(dǎo)致纖維化、肝硬化及其

20、他潛在并發(fā)癥的發(fā)生Steatosis is also becoming more common especially in Western countries肝脂肪變性越來越普遍，特別在西方國家Might also lead to fibrosis when progresses to Alcoholic or Non Alcoholic Steatohepatitis (ASH or NASH)當(dāng)進(jìn)展為酒精性或非酒精性脂肪性肝炎

21、也可能會導(dǎo)致纖維化,Introduction (2)介紹,[1] :Friedrich Rust et al., Gastroenterology 2008 [2] Sasso et al. Journal of Viral Hepatitis 2011,9,Introduction,FibroScan® measures two quantitative parameters in a non-invasive and p

22、ainless way :Fibroscan用無創(chuàng)和無痛的方法測量兩個定量參數(shù),FibroScan® is based on Vibration Controlled Transient Elastography (VCTETM) at 50Hz.Fibroscan是基于振動控制瞬時彈性成像技術(shù)（頻率為50Hz）,Elastography Principle彈性成像原理,What is stiffness ?什么是硬度 ?

23、,07/2011,,11,Elastography Principle,Quantifies the ability of a medium not to get out of shape when under mechanical stress硬度是介質(zhì)承受機(jī)械壓力時的抗變形程度的量化表示Stiffness or Elastic modulus or Young’s modulus are expressed in Pascal

24、(Pa)硬度或彈性模量或楊氏模量用 Pascal(Pa)表示。,,硬度,彈性模量,楊式模量,彈性,Why measure stiffness ?為什么測量硬度?,07/2011,,12,Elastography Principle,Stiffness is a key parameter depending on the pathological state of soft tissues硬度對于軟組織的病理狀態(tài)而言是一個關(guān)鍵參數(shù)

25、For centuries, physicians have used liver palpation 幾個世紀(jì)以來, 醫(yī)生已經(jīng)用肝臟觸診。,How do we measure stiffness ?怎樣測量硬度 ?,07/2011,,13,Elastography Principle,In soft tissues, stiffness is related to the velocity of elastic waves cal

26、led shear waves.在軟組織中, 硬度與彈性波（剪切波）傳播速度相關(guān).Shear waves are widely present in biological tissues…剪切波廣泛存在于生物組織中,The stiffer the tissue, the faster the shear waves組織硬度越高，剪切波傳播速度越快,Generate a shear wave within the liver肝臟

27、內(nèi)生成一個剪切波,Measure its speed of propagation VS測量傳播的速度 VS,Stiffness硬度E ? VS2,Stiffness Measurement Principle硬度測量原理,Velocity of the Shear Wave剪切波的速度,07/2011,,15,Stiffness Measurement Principle,Comparison of consecutive ul

28、trasonic signals to map the local strain of the medium.對連續(xù)的超聲信號進(jìn)行比較，定位介質(zhì)中發(fā)生的局部應(yīng)變。The strain rate image (elastogram) is NOT an anatomical image, it is the representation of the shear wave propagation through li

29、ver tissue as function of time.彈性圖不是解剖圖像，它作為時間的函數(shù)，表示剪切波在肝組織中的傳播,Strain rate image應(yīng)變率圖像,Time (ms),皮下深度（毫米）,,,dt,Examples in Human Liver在人體肝臟中的實(shí)例,07/2011,,16,Stiffness Measurement Principle,VS = 1.1 m/sE ~ 3 kPa,VS = 1.

30、7 m/sE ~ 9 kPa,VS = 3.6 m/sE ~ 40 kPa,E ? VS2,,The more fibrosis in the liver, the higher stiffness will be 肝臟纖維化程度越高，肝臟硬度值越大*,Vibration Controlled Transient Elastography (VCTE TM)振動控制瞬時彈性成像,,,17,By courtesy of Rheol

31、ution Inc.,50 Hz controlled frequency,Thanks to VCTE? technology, shear wave speed and equivalent liver stiffness measurement with FibroScan® are:感謝VCTE技術(shù)，F(xiàn)ibroscan中的剪切波速度和相應(yīng)的肝臟硬度測量是：Repeatable and reproducible可重復(fù)的

32、和可再生的Independent of device and operator不受設(shè)備和操作者的影響Independent of organ movements (breathing, heartbeat,…)不受器官運(yùn)動的影響（呼吸、心跳。。。）,Influence of shear wave frequency (Hz) on stiffness measurement (kPa),Stiffness measurement p

33、rinciple,CAP MeasurementPrinciple CAP 測量原理,What is CAP? 什么是CAP?,,19,CAP principle,CAP? (Controlled Attenuation Parameter) allows quantification of the decrease of the amplitude of the ultrasonic signals in the liver.控制

34、衰減參數(shù)被用來對肝臟中超聲波信號振幅的衰減進(jìn)行定量,Definition: CAP is based on the quantification of the ultrasonic attenuation in the liver tissue. 定義：CAP是基于肝臟組織中超聲波衰減的定量This attenuation/decrease depends on:這種衰減/下降決定于：Distance of propagation

35、of the ultrasonic signals into the medium超聲波信號在介質(zhì)中傳遞的距離The deeper in the tissue the weaker the ultrasonic signal傳遞的越深信號越弱Properties of the medium such as viscosity媒介的性質(zhì)例如粘性Fat content (steatosis) will affect the visc

36、osity of the medium脂肪含量（脂肪變性）將影響媒介的粘性,CAP? main features主要特性,CAP principle,* Sasso et al. Journal of viral hepatitis 2011,Quantitative parameter expressed in dB/meter以dB/米表示的定量參數(shù)Reflects the decrease in amplitude of ul

37、trasound in the liver反應(yīng)超聲波在肝臟中的振幅下降程度Computed from the ultrasounds acquired for stiffness measurement使用硬度測量時所發(fā)生的超聲波計(jì)算Displayed only if liver stiffness measurement is valid僅在肝臟測量有效時才顯示Independent of the device and of

38、the operator unlike conventional ultrasonography不像傳統(tǒng)的超聲波檢查受設(shè)備和操作者的影響,,21,CAP Measurement Principle,CAP value increases with steatosis in liver tissue.CAP值隨肝臟組織脂肪變程度的增加而升高,Acquisition with FibroScan® MProbe用M探頭測定,U

39、ltrasonic signal超聲波信號,Elastogram彈性圖,Valid stiffness measurement有效硬度測量,NO,No result無結(jié)果,,,Invalid measurement,Explored volume探查體積,,22,CAP Measurement Principle,CAP and stiffness measurements are done simultaneously.CAP與硬

40、度測量同時進(jìn)行,la sonde,,-,Measurement Principle測量原理,,23,Stiffness & CAP Measurement Principle,Click on « Play »,Presentation of the Device設(shè)備介紹,FibroScan® 502,07/2011,,25,Presentation of the Device

41、,? 一體化計(jì)算機(jī)Integrated computer數(shù)據(jù)獲取軟件Acquisition software檢查記錄列表List of stored examinations,? 電子設(shè)備Dedicated electronics超聲發(fā)射接收探頭Ultrasound emission/reception 低頻振動發(fā)生器 Shear wave generation信號處理程序 Signal proces

42、sing,The Probe 探頭,07/2011,,26,Presentation of the Device,Blue diodes藍(lán)色指示針,Button開關(guān),Vibrator振動發(fā)生器,,,,,Ultrasonictransducer超聲轉(zhuǎn)換器,Starting up the system系統(tǒng)開機(jī),07/2011,,27,Presentation of the Device,Connect the system to th

43、e mains and 連上設(shè)備Put the power switch in the | position 將開關(guān)放在I檔,Connect the probe to the system 插入探頭,07/2011,,28,Presentation of the Device,Automatically loaded at power on打開后自動載入,,Configuration access設(shè)置窗口,Archives

44、 access檔案窗口,Acquisition access數(shù)據(jù)獲取窗口,,,The Software 軟件,07/2011,29,,Presentation of the Device,Archives 檔案管理,Acquisition 數(shù)據(jù)獲取,The software: 2 main windows2個主要界面,07/2011,30,,Presentation of the Device,Number of patie

45、nt files matching the search符合標(biāo)準(zhǔn)的患者數(shù)量,Selected patient file選定患者信息,Patient files management tools患者檔案管理,,Selected patient and corresponding examinations summary挑選的病人和檢測數(shù)據(jù),Archives window 檔案窗口,07/2011,31,,Presentation

46、of the Device,,UltrasonicImages 超聲影像,,Elastogram彈性圖,,Number and List of valid measurements (kPa)有效測定次數(shù)與列表,,CAP ResultsCAP值,StiffnessResults硬度值,,Acquisition window數(shù)據(jù)獲取窗口,,Invalid measurements and success rate無效測

47、定和成功率,Pressure Indicator壓力指示器,07/2011,,32,Presentation of the Device,One red line一條紅線Pressure too lowfor measurement 測量壓力過低,Green level綠線Pressure suitableto trigger measurement 測量壓力適宜,Red level 紅線Pre

48、ssure too highfor measurement 測量壓力過高,,Caution 提示Pressure on S probe is very sensitive !s探頭對壓力非常敏感,Ultrasonic Imaging超聲影像,07/2011,,33,Presentation of the Device,,Depth below the skin surface (mm),Time,,,,TM mo

49、de TM模式Ultrasonic AmplitudeAs function of depth and time超聲振幅和時間與深度的關(guān)系,,A mode A模式Ultrasonic signal Amplitude as function of depth超聲深度信號,,CAP value CAP值Current measurement in dB/m 測量以dB/m表示,提示：測量值同時包含肝臟硬度值與CAP 值

50、 探頭類型有（S 1、S 2、中號、加大號）,,Stiffness and CAP Results硬度和CAP結(jié)果,,34,Presentation of the Device,Stiffness 硬度(kPa) or CAP (dB/m) Median of all valid measurements within the current examination包括當(dāng)前測量在內(nèi)所有有效測定結(jié)果的中位數(shù),IQ

51、R (kPa or dB/m)四分位間距Inter quartile range of all valid measurements within the current examination所有有效測量值的四分位間距 Reflects the dispersion/homogeneity of stiffness or CAP measurements反應(yīng)硬度和CAP測量的離散型和一致性IQR/med. (%) Indica

52、tes the IQR/median ratio表示四分位間距/中位數(shù)Must remain as low as possible to ensure reliable results此值必須足夠的低以保證結(jié)果可靠,34,,,,Reminder: median and IQR提醒：中位數(shù)和四分位間距,,35,Presentation of the Device,,,,,,,,,,,,M1,M2,M3,M4,M5,M6,M7,M8,M9

53、,M10,35,Sort the valid measurements in an ascending order (from M1 to M10)將有效測量值升序排列（從M1到M10） Median Q2 divides the ordered data set into two halves中位數(shù)Q2將排列好的數(shù)據(jù)劃分為兩部分,Median,Select and Launch an Examination選擇和啟動檢查,Exam

54、ination selection,Select and Launch an Examination,07/2011,,37,探頭選擇,,S1探頭,不是,不推薦,M Probe M探頭,,39,Select and Launch an Examination,S Probe,XL Probe,Next,,,,S Probe S探頭,Select and Launch an Examination,,40,S probe,XL Probe

55、,Next,,,XL Probe XL探頭,Select and Launch an Examination,,41,07/2011,,42,Use of Ultrasonic Device超聲設(shè)備的用途,Select and Launch an Examination,Measure skin-capsule depth (SCD) :Ultrasonic imaging is used to assess the SCD.超聲

56、影像用于測量SCDLocalize the liver :肝臟定位Ultrasonic imaging also allows you to choose a measurement point where liver parenchyma is deep enough with optimal SCD.超聲影像幫助您選取一個最理想SCD值的位置作為測量點(diǎn)。,If 2.5 cm ≤ SCD < 3.5 cm, choose

57、 the XL Probe如果2.5 cm ≤ SCD < 3.5 cm，選擇XL探頭,Main software options主要軟件選擇,Select and Launch an Examination,,43,Changing exam type改變檢測類型Change of probe cannot be done within the examination檢測中不能更換探頭End the current exa

58、mination and plug the new probe under the tray結(jié)束目前的檢測并在托盤下插入新探頭Start another examination開始下一個檢測,Erase measurements during examination檢測中刪除檢測結(jié)果A group of measurements is deleted. Median, IQR and IQR/Median ratio are up

59、dated accordingly.刪除一組檢測數(shù)據(jù)之后，中位數(shù)、四分位間距和中位數(shù)間距/中位數(shù)相應(yīng)發(fā)生改變,Patient Examination procedure患者檢查流程,Patient Positioning 患者體位,Patient Examination,20/03/2024,,45,Measurement on the right lobe of the liver between the ribs. 測

60、量肋間的肝臟右葉Patient in dorsal decubitus position with the right arm in maximal abduction. 患者仰臥位，右臂最大限度伸展If the patient is stressed, measurements can be performed whilst the patients hold their breath. 如果病人受壓（壓迫

61、感），可以屏息測量,07/2011,45,,Operator Positioning操作者位置,Patient Examination,Operator sitting on a stool or a chair with wheels on the right side of the patient facing both the patient’s chest and the screen of the device.

62、 操作者坐在患者右側(cè)的凳子或椅子上，面向病人的胸部和儀器屏幕。Right forearm should rest on the bed along the patient’s chest. 右前臂應(yīng)該沿著患者的胸腔放在床上。All the weight of the probe should be within the right hand. 所有探頭的承重都應(yīng)在右手上。The left hand hel

63、ps keeping the probe correctly positioned. 左手幫助保持探頭處在正確的位置。,07/2011,,46,Probe Positioning (1)探頭位置（1）,Patient Examination,Place the probe between the ribs adjacent to the right lobe of the liver in the middle of th

64、e parenchyma away from the border of the liver. If you are too close to the border the liver, stiffness will be overestimated. 將探頭放在肋骨間，近肝臟右葉，肝實(shí)質(zhì)中間，遠(yuǎn)離肝臟邊緣。 如果與肝臟的邊界太近，硬度值將被高估。The location where a liver biopsy wo

65、uld be performed should suit. 適合肝活檢的位置應(yīng)該合適。Dullness at percussion 叩診濁音處Sternum and mid auxiliary line 胸骨和中部輔助線,07/2011,,47,Probe Positioning (2)探頭位置 (2),Patient Examination,Use the A mode and M mode i

66、mages to find a liver portion at least 6-cm deep free of large vascular structures 使用 A 模式和 M 模式圖像，找到?jīng)]有大血管結(jié)構(gòu)的至少6cm深度的肝臟部分,07/2011,,48,Probe Positioning (3)探頭位置(3),Patient Examination,Keep the probe perpendicular t

67、o the skin surface or the liver stiffness will be overestimated. 保持探頭與皮膚表面垂直，否則肝臟硬度將會過高。Make sure you check the perpendicularity along both axes by looking at the probe. 通過觀察，確保探頭沿兩軸垂直。,07/2011,,49,,Increa

68、se the pressure applied with the probe on the patient’s skin until the pressure indicator is in the green level.按壓與患者皮膚接觸的探頭，直至壓力指示器在綠色區(qū)域。,CAUTION : Keeping the perpendicularity of the probe may be difficult with childr

69、en (S probe)注意：在使用S探頭給兒童做檢測時，保持探頭的垂直有一定難度！,Measurement測量,Patient Examination,When all the conditions mentioned above are met you can trigger a measurement. 當(dāng)上面提到的所有條件得到滿足時，可以進(jìn)行測量。Press the button on the probe wi

70、thout changing the probe position. 按壓探頭上按鈕，并避免探頭移動。Acquisition lasts a tenth of second and calculation a few seconds. 數(shù)據(jù)獲取持續(xù)1/10秒的時間，同時計(jì)算幾秒鐘。Then the result of this measurement is displayed. 顯示測量結(jié)果