GIVEN-PillCam膠囊內(nèi)鏡應(yīng)用與新產(chǎn)品進(jìn)展

PillCam

膠囊內(nèi)鏡臨床應(yīng)用與新進(jìn)展2

2/14/2025PillCam小腸鏡SB226.3mm11.4mm三透鏡鏡頭組，微距對(duì)焦準(zhǔn)確真156°視野角，可視面積是140°角的兩倍自動(dòng)閃光亮度調(diào)節(jié)ESGEGuidelines

KeypointsforSBCESBCEisthefirstlineexaminationforOGIBafteranegativeupperandlowerexamPatientswithunexplainedIDAshouldundergoSBCESBCEisthebestproceduretoevaluatesmallbowelmucosallesionsin

Crohn’s

diseaseSBCEinfluencesthetherapeuticwork-upofsmallboweltumors3LadasSD.etal.EuropeanSocietyofGastrointestinalEndoscopy(ESGE):recommendations(2009)onclinicaluseofvideocapsuleendoscopytoinvestigatesmall-bowel,esophagealandcolonicdiseases.Endoscopy2010:42:220-227Meta-Analysis

GooddiagnosticyieldofSBCEvs.othermethodologiesinOGIBThreestudies(n=88patients)showedayieldforCEof67%vs8%forsmallbowelradiographyCEissuperiortopushendoscopyandSBbariumradiographyfordiagnosisclinicallysignificantpathologyinpatientswithOGIBTheincrementalyieldofCEoverthesemethodsis>30%duetovisualizationofadditionalvascularandinflammatorylesions4TriesterSLetal.AMeta-analysisoftheYieldofCapsuleEndoscopyComparedtoOtherDiagnosticModalitiesinPatientswithObscureGastrointestinalBleeding.AmJGastro2005;100:2407-2418MonitoringmucosalhealinginpatientswithCrohn'sDiseaseCovidienRespiratoryandMonitoringSolutions|February14,2025|Confidential5|PillCamSB:ClearancefromFDAforVisualizationandMonitoringofLesionsIndicativeofCrohn’sDisease(2011,March)ECCOGuidelineforpatientswithCrohn'sDiseaseSBCEmaybebetterthansmallbowelfollow-throughorenteroclysisatidentifyingsmallbowelmucosallesionsconsistentwithCrohn’sSBCEmaybesuperiortoMRenterography,CTEorCTenteroclysisfordetectingmucosallesionsconsistentwithCrohn’sSBCEhasthepotentialroleintheassessmentofmucosalhealingafterdrugtherapySBCEcanbehelpfulinidentifyingmucosallesionscompatiblewithCrohn’sinpediatric

patients6BourreilleAetal.RoleofSmall-BowelEndoscopyintheManagementofPatientswithInflammatoryBowelDisease:AnInternationalOMED-ECCOConsensus.Endoscopy2008;41:618-637KeypointsforSBCE–LewisScoreLewisScore:AusefulclinicaltoolforpatientswithsuspectedCrohn'sDiseasesubmittedtocapsuleendoscopyTheLewisScore(LS)canassessinflammatoryactivityonsmallbowelcapsuleendoscopy(SBCE)7RosaBetal.JournalofCrohn'sandColitis(2012)6,692–697ImpactofCEonmanagementofIBD907patients,retrospective

ThisstudyofpatientsevaluatedwithCEforCDshowedthatachangeinmedicationmanagementoccurred62%ofthetime 8LongMDetal.Impactofcapsuleendoscopyonmanagementofinflammatoryboweldisease:asingletertiarycarecenterexperience.InflammBowelDis.2011Sep;17(9):1855-62.Evaluationof30consecutivepediatricpatientswithknownUC(14males,meanage14.1±3.2years)andcandidatesforcolonoscopyNoseriousadverseeventsCCEhadahigheroveralltolerability(p<0.05)CCEshowsgooddiagnosticaccuracyandinter-observeragreementwasexcellentinallcases9Olivaetal.Endoscopy2014CCEmayplayanimportantroleinpediatricUCCCEinpatientswithulcerativecolitis42patientswithknownUlcerativeColitisandindicationforcolonoscopyunderwentbothcoloncapsuleendoscopyandcolonoscopyTherewasagoodcorrelationbetweenCCEandcolonoscopyindiseaseseverityandextentofinflammationTheabilityofcoloncapsuleendoscopytoassessdistalileumisanadvantageofthecoloncapsuleendoscopy,becausepathologicalfindingsatthislevelcanchangetheoriginaldiagnosisofUC10SanJuan-AcostaM.etal.Coloncapsuleendoscopyisasafeandusefultooltoassessdiseaseparametersinpatientswithulcerativecolitis.EurJGastroenterolHepatol26:894–901治療前后CE監(jiān)測(cè)：黏膜愈合客觀評(píng)估以膠囊內(nèi)鏡評(píng)估infliximab治療難治性CD的療效：近期緩解率內(nèi)鏡/組織學(xué)愈合率Calabreseetal.AlimentPharmacolTher.2008;27(9):759-764.BeforeTherapyAfterTherapyPillCamSB2在慢性腹痛伴或無(wú)腹瀉患者診斷及臨床意義72例慢性腹痛伴或無(wú)腹瀉癥狀。6中心研究。結(jié)果：總陽(yáng)性診斷率44.4%，特別的是：結(jié)論:慢性腹痛伴或不伴腹瀉患者，如同時(shí)有炎癥檢查標(biāo)志物陽(yáng)性，行膠囊內(nèi)鏡檢查可獲得較高的陽(yáng)性診斷率.陽(yáng)性結(jié)果對(duì)臨床治療有高度的指導(dǎo)意義12

2/14/2025P.Katsinelosetal./EuropeanJournalofInternalMedicine22(2011)e63–e66診斷率腹痛CRP/ESR腹瀉21.4%+－－66.7%++－0%+－+90.1%+++PillCamSB2用于代償性肝硬化的小腸病變觀察60例門(mén)脈高壓患者，特別是代償性肝硬化伴貧血患者的小腸病變的發(fā)生情況。40例存在小腸病變（67%），紅斑（53%），糜爛（17%）、血管擴(kuò)張（15%）、靜脈曲張（7%）、絨毛消腫（7%）。病變與臨床因素的相關(guān)性為Child-Pugh分級(jí)B級(jí)比A級(jí)有更高相關(guān)性，腹水比無(wú)腹水相關(guān)性高（P＝0.0085），存在門(mén)脈高壓性胃病比無(wú)門(mén)脈高壓性胃病相關(guān)性高（P=0.0434）結(jié)論：膠囊內(nèi)鏡在代償性肝硬化患者的小腸病變?cè)\斷中是一個(gè)有效的診斷方法。13

2/14/2025PillCamSB2用于缺鐵性貧血24項(xiàng)研究1960例CE對(duì)IDA的匯總診斷率為47%。僅以IDA為檢查指征的研究匯總診斷率為66.6%，而指征不限于IDA的研究匯總診斷率為44%。在僅以IDA為檢查指征的研究中，患者更可能檢出血管性、炎癥性和占位/腫瘤病變。14

2/14/2025KoulaouzidisA,etal.GastrointestEndosc.2012Nov;76(5):983-9215PillCamColon2結(jié)腸膠囊雙攝像頭大視野角長(zhǎng)工作時(shí)拍攝變頻16結(jié)腸1視野角1560結(jié)腸2視野角1720:接近

3600

全覆蓋PillCamCOLON2C2172C11560017DR3數(shù)據(jù)記錄儀18DR3數(shù)據(jù)記錄儀的智能功能實(shí)時(shí)對(duì)采集的全部圖像進(jìn)行分析自動(dòng)識(shí)別

自動(dòng)識(shí)別結(jié)腸膠囊離開(kāi)胃部進(jìn)入小腸自動(dòng)提醒患者和操作者按照預(yù)先規(guī)劃完成操作(如服促進(jìn)藥物，餐食，檢查中止等)19實(shí)時(shí)觀看每側(cè)攝像頭所攝圖像，并可在觀看時(shí)實(shí)時(shí)捕捉圖像。智能電源管理保證記錄儀超過(guò)18小時(shí)的連續(xù)工作時(shí)間DR3數(shù)據(jù)記錄儀20根據(jù)膠囊狀態(tài)（靜止或移動(dòng)）自動(dòng)調(diào)整膠囊工作頻率自調(diào)拍攝頻率

(AFR)

當(dāng)膠囊為相對(duì)靜止?fàn)顟B(tài)時(shí)攝像頻率為4幀

/秒

當(dāng)膠囊為運(yùn)動(dòng)狀態(tài)時(shí)，拍攝頻率為35幀

/秒獲取更多的結(jié)腸表面圖像節(jié)約電池能量?jī)?yōu)化視頻長(zhǎng)度214/2imagespersec

模擬結(jié)腸一代

35/2imagespersec

結(jié)腸二代自調(diào)拍攝頻率(AFR)

22RAPID軟件中的息肉大小估測(cè)同一息肉的膠囊所見(jiàn)14mm15mm14mm14mm直接測(cè)量顯示大小，不因視野中息肉大小不同而改變測(cè)量數(shù)值PillCamCOLON2

23|PillCamCOLON2結(jié)腸膠囊是一種非侵入性，無(wú)痛而且安全的工具，可用于觀察結(jié)腸黏膜。TheESGEGuidelinestatesthat:“CCEisfeasibleandsafeandappearstobeaccuratewhenusedinaverageriskindividuals”“CCEisafeasibleandsafetoolforvisualizationofthecolonicmucosainpatientswithincompletecolonoscopyandwithoutstenosis”P(pán)illCamCOLON2適應(yīng)癥息肉/癌癥

ESGE指南:結(jié)腸膠囊CCE一種安全可靠可行的方法:在一般風(fēng)險(xiǎn)的患者中患者結(jié)腸鏡檢查未能完成患者不愿意進(jìn)行結(jié)腸鏡檢查無(wú)法進(jìn)行普通結(jié)腸鏡檢查24結(jié)腸膠囊用于預(yù)防結(jié)直腸癌結(jié)腸篩查25|優(yōu)勢(shì):直接觀察腸黏膜在息肉檢查上有高診斷準(zhǔn)確度檢查方式靈活，可以院外進(jìn)行安全

無(wú)侵入性，無(wú)痛，無(wú)需麻醉鎮(zhèn)靜

無(wú)需充氣，無(wú)放射性

患者劣勢(shì):僅可用于診斷

需要進(jìn)行特別的技巧培訓(xùn)

發(fā)現(xiàn)病變的患者仍傳統(tǒng)結(jié)腸鏡手術(shù)價(jià)格昂貴

26HighaccuracyforpolypdetectionofCCEvs.colonoscopyin3trialsSpadaetal.,GIE2011;74(3):581-589.,Eliakimetal.,Endoscopy2009;41:1026-1031.,Rexetal.,GastrointestEndosc.2013;77(5)SuppAB703.27IncompleteColonoscopy

CCEissuperiortoCTC100patientsafterincompletecolonoscopyunderwentCCEandCTCandachievedcompletecolonicevaluationin98%DiagnosticYieldofCCEissuperiortoCTC,especiallyin6-9mmandnon-polypoidlesionsCCEmaybeconsideredasfirst-choicetestforpatientsafterincompletecolonoscopySpadaetal.GUT2014DiagnosticyieldofCCEandCTCforpolyps≥6mmand≥10mmDiagnosticyield%Polyps>6mmCCE24,5CTC12,2Polyps>10mmCCE5,1CTC3,1Seethedifference:Indirect(CTC)versusdirect(CCE)smallpolypvisualizingPillcamColon2vsColonoscopySensitivitySpecificityAdenoma>=6mm>=10mm88%(82-93%)92%(82-97%)