GIVEN-PillCam胶囊内镜应用与新产品进展

PillCam

胶囊内镜临床应用与新进展2

2/14/2025PillCam小肠镜SB226.3mm11.4mm三透镜镜头组，微距对焦准确真156°视野角，可视面积是140°角的两倍自动闪光亮度调节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治疗前后CE监测：黏膜愈合客观评估以胶囊内镜评估infliximab治疗难治性CD的疗效：近期缓解率内镜/组织学愈合率Calabreseetal.AlimentPharmacolTher.2008;27(9):759-764.BeforeTherapyAfterTherapyPillCamSB2在慢性腹痛伴或无腹泻患者诊断及临床意义72例慢性腹痛伴或无腹泻症状。6中心研究。结果：总阳性诊断率44.4%，特别的是：结论:慢性腹痛伴或不伴腹泻患者，如同时有炎症检查标志物阳性，行胶囊内镜检查可获得较高的阳性诊断率.阳性结果对临床治疗有高度的指导意义12

2/14/2025P.Katsinelosetal./EuropeanJournalofInternalMedicine22(2011)e63–e66诊断率腹痛CRP/ESR腹泻21.4%+－－66.7%++－0%+－+90.1%+++PillCamSB2用于代偿性肝硬化的小肠病变观察60例门脉高压患者，特别是代偿性肝硬化伴贫血患者的小肠病变的发生情况。40例存在小肠病变（67%），红斑（53%），糜烂（17%）、血管扩张（15%）、静脉曲张（7%）、绒毛消肿（7%）。病变与临床因素的相关性为Child-Pugh分级B级比A级有更高相关性，腹水比无腹水相关性高（P＝0.0085），存在门脉高压性胃病比无门脉高压性胃病相关性高（P=0.0434）结论：胶囊内镜在代偿性肝硬化患者的小肠病变诊断中是一个有效的诊断方法。13

2/14/2025PillCamSB2用于缺铁性贫血24项研究1960例CE对IDA的汇总诊断率为47%。仅以IDA为检查指征的研究汇总诊断率为66.6%，而指征不限于IDA的研究汇总诊断率为44%。在仅以IDA为检查指征的研究中，患者更可能检出血管性、炎症性和占位/肿瘤病变。14

2/14/2025KoulaouzidisA,etal.GastrointestEndosc.2012Nov;76(5):983-9215PillCamColon2结肠胶囊双摄像头大视野角长工作时拍摄变频16结肠1视野角1560结肠2视野角1720:接近

3600

全覆盖PillCamCOLON2C2172C11560017DR3数据记录仪18DR3数据记录仪的智能功能实时对采集的全部图像进行分析自动识别

自动识别结肠胶囊离开胃部进入小肠自动提醒患者和操作者按照预先规划完成操作(如服促进药物，餐食，检查中止等)19实时观看每侧摄像头所摄图像，并可在观看时实时捕捉图像。智能电源管理保证记录仪超过18小时的连续工作时间DR3数据记录仪20根据胶囊状态（静止或移动）自动调整胶囊工作频率自调拍摄频率

(AFR)

当胶囊为相对静止状态时摄像频率为4帧

/秒

当胶囊为运动状态时，拍摄频率为35帧

/秒获取更多的结肠表面图像节约电池能量优化视频长度214/2imagespersec

模拟结肠一代

35/2imagespersec

结肠二代自调拍摄频率(AFR)

22RAPID软件中的息肉大小估测同一息肉的胶囊所见14mm15mm14mm14mm直接测量显示大小，不因视野中息肉大小不同而改变测量数值PillCamCOLON2

23|PillCamCOLON2结肠胶囊是一种非侵入性，无痛而且安全的工具，可用于观察结肠黏膜。TheESGEGuidelinestatesthat:“CCEisfeasibleandsafeandappearstobeaccuratewhenusedinaverageriskindividuals”“CCEisafeasibleandsafetoolforvisualizationofthecolonicmucosainpatientswithincompletecolonoscopyandwithoutstenosis”PillCamCOLON2适应症息肉/癌症

ESGE指南:结肠胶囊CCE一种安全可靠可行的方法:在一般风险的患者中患者结肠镜检查未能完成患者不愿意进行结肠镜检查无法进行普通结肠镜检查24结肠胶囊用于预防结直肠癌结肠筛查25|优势:直接观察肠黏膜在息肉检查上有高诊断准确度检查方式灵活，可以院外进行安全

无侵入性，无痛，无需麻醉镇静

无需充气，无放射性

患者劣势:仅可用于诊断

需要进行特别的技巧培训

发现病变的患者仍传统结肠镜手术价格昂贵

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%)