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ProgramsinLiver

PreconceptionCareReducesIBDDuring

RecurrentAcutegySeptemberVolume14NumberSeptemberControlledForDetectingGastricDiseaseSeePage1266ALSO:ALSO:QUALITYIMPROVEMENTPRIMER#2 Vol.14,No.9,SeptemberONTHEAccuracyofmagneticallycontrolledcapsuleendoscopyfordetectinggastricdisease.SeeLiaoZetalonpage1266.IMAGESOFTHE AUniqueCaseofDiffuseIntestinalandColonicM.Uzzan,O.Corcos,andD. ColonoscopyEnablestheDiagnosisofOpiateP.Copland,J.P.Gaspar,andA.Y. ARareHepaticTumorMimickingHepatocellularCarcinomainaPatientWithHepatitisCCirrhosisT.Aasen,A.Pa,andN.M.ELECTRONICIMAGESOFTHEAvailableonlyonline ProximalEsophagealVarices:ARareYetTreatableCauseofD.P.Rhoades,K.A.Forde,andJ.H. AnUnusualCauseofLarge-BowelObstruction:CholecystocolonicFistulaandGallstoneIleusJ.W.T.Toh,H.Balasuriya,andP. ARareCauseofIschemicL.Wang,C.C.M.Cho,andA.W.H. ARareCaseofChronicDiarrheaandWeightH.He,S.Mei,andL.ISSUE H.RelatedarticleinGASTROVVGECME paniesthis Additionalonlinecontent EPublisher:ClinicalGastroenterologyandHepatology(ISSN15423565)ispublishedmonthlybyElsevierInc,360ParkAvenueSouth,NewYork,NY100101710.PeriodicalspostagepaidatNewYork,NYandadditionalmailingoffices.Postmaster:SendaddresschangestoClinicalGastroenterologyandHepatology,ElsevierHealthSciencesDivision,SubscriptionCustomerService,3251RiverportLane,MarylandHeights,MO63043.PRACTICEMANAGEMENT:THEROAD QualityImprovementPrimerSeries:ThePlan-Do-Study-ActCycleandDataN.Bollegala,K.Pa,J.D.Mosko,M.Bernstein,M.Brahmania,L.Liu,A.H.Steinhart,S.S.C.M.Bell,G.C.Nguyen,andA.V.SINCLINICALGASTROENTEROLOGYAND NewEndoscopicTechnologiesandProceduralAdvancesforEndoscopic tandK.F.ORIGINALSystematicReviewsandMeta- MucosalHealingIsAssociatedWithImprovedLong-term esofPatientsWithS.C.Shah,J.–F.Colombel,B.E.Sands,andN. CME/MOCACTIVITY:Exam1:MucosalHealingIsAssociatedWithImproved esofPatientsWithUlcerativeColitis:ASystematicReviewandMeta-ysis BuildingEffectiveQualityImprovementProgramsforLiverDisease:ASystematicReviewE.B. CME/MOCACTIVITY:Exam2:BuildingEffectiveQualityImprovementProgramsforLiverDisease:ASystematicReviewofQualityImprovementInitiativesEE

AlimentaryAccuracyofMagneticallyControlledCapsuleEndoscopy,ComparedWithConventionalGastroscopy,inDetectionofGastricDiseasesZ.Liao,X.Hou,E.–Q.Lin–Hu,J.–Q.Sheng,Z.–Z.Ge,B.Jiang,X.–H.Hou,J.–Y.Liu,Z.Li,Q.–Y.X.–J.Zhao,N.Li,Y.–J.Gao,Y.Zhang,J.–Q.Zhou,X.–Y.Wang,J.Liu,X.–P.Xie,C.–M.Yang,H.–L.Liu,T.Sun,W.–B.Zou,andZ.–S.IncreasedPostoperativeMortalityandComplicationsAmongElderlyPatientsWithInflammatoryBowelDiseases:An ysisoftheNationalSurgicalQualityImprovementProgramCohortN.Bollegala,T.D.Jackson,andG.C. EDITORIAL:ToOperateorNottoOperateinInflammatoryBowelDisease:IsOlderAgetheOnlyQuestion?C. PreconceptionCareReducesRelapseofInflammatoryBowelDiseaseA.deLima,Z.Zelinkova,A.G.M.G.J.Mulders,andC.J.vander EDITORIAL:TheBirds,theBees,andInflammatoryBowelDisease:PreconceptionCareinInflammatoryBowelDiseaseR.A.McConnellandU. PouchitisIsaCommonComplicationinPatientsWithFamilialAdenomatous K.P.Quinn,A.L.Lightner,R.S.Pendegraft,F.T.Enders,L.A.Boardman,andL.E.

AppropriatenessofTestingforAnti–TumorNecrosisFactorAgentandAntibodyConcentrations,andInterpretationofResultsB.Bressler,A.S.Cheifetz,S.M.Devlin,L.E.Raffals,N.V.Casteele,D.R.Mould,J.–F.M.Dubinsky,W.J.Sandborn,andC.A.IncreasedRiskofAdvancedColorectalNeoplasiaAmongKoreanMenWithMetabolicAbnormalityandObesityJ.Y.Kim,D.IlPark,J.Yu,Y.S.Jung,J.H.Park,H.J.Kim,Y.K.Cho,C.IlSohn,W.K.B.IkKim,andK.Y.Pancreas,BiliaryTract,andTotalPancreatectomyWithIsletAutotransplantationImprovesQualityofLifeinPatientsWithRefractoryRecurrentAcutePancreatitisM.D.Bellin,T.Kerdsirichairat,G.J.Beilman,T.B.Dunn,S.Chinnakotla,T.L.Pruett,D.R.S.J.Schwarzenberg,D.E.R.Sutherland,M.A.Arain,andM.L. ContinuingDecreaseinHepatitisB Infection30YearsAfterInitiationofInfantVaccinationPrograminY.–H.Ni,M.–H.Chang,C.–F.Jan,H.–Y.Hsu,H.–L.Chen,J.–F.Wu,andD.–S. ficationofCoreAntigenMonitorsEfficacyofDirect-actingAntiviralAgentsinPatientsWithChronicHepatitisC A.Aghemo,E.Degasperi,S.DeNicola,P.Bono,A.Orlandi,R.D’Ambrosio,R.Soffredini,R.G.Lunghi,andM.E AssociationofNonalcoholicFattyLiverDiseaseWithVisceralAdipositybutNotCoronaryArteryCalcifiEK.Jacobs,S.Brouha,R.Bettencourt,E.Barrett–Connor,C.Sirlin,andR. EDITORIAL:NonalcoholicFattyLiverDiseaseandCoronaryArteryN. EffectsofArsenicinDrinkingWateronRiskofHepatitisorCirrhosisin sWithandWithoutChronicViralHepatitisL.–I.Hsu,Y.–H.Wang,F.–I.Hsieh,T.–Y.Yang,R.Wen–JueiJeng,C.–T.Liu,C.–L.Chen,K.–H.Hsu,Y.Chiou,M.–M.Wu,andC.–J. NoDifferencesinAchievingHepatitisC tonesBetweenPatientsIdentifiedbyBirthCohortorRisk-BasedScreeningB.L.Norton,W.N.Southern,M.Steinman,B.D.Smith,J.Deluca,Z.Rosner,andA.H.LETTERSTOTHE MucosalHealingintheTreatmentofUlcerativeColitis:AReliableC.Dai,M.Jiang,andM.–J. S.C.Shah,J.–F.Colombel,B.E.Sands,andN. UnderstandingBreathTestsforSmallIntestinalBacterialK.TriantafyllouandM. T.MasseyandE.C. DietaryChallengeTests:IdentifyingFoodIntoleranceasaCauseofSymptomsinIrritableBowelSyndromePatientsY.Deng,Y.Zhu,N.Dai,andM. Letterto“StatinUseIsAssociatedWithReducedRiskofColorectalCancerinPatientsWithInflammatoryBowelDiseases”V.Boccardi,L.Marano,andG.MULTIMEDIA TheCrohn’sDisease–UlcerativeColitisClinicalAppraisalUpdate:EmergingTrendsinClinicalPracticeW.Sandborn,J.–F.Colombel,G.D’Haens,S.Ghosh,R.Panaccione,J.Panés,S.Travis,L.CENTERCITY,NY10001-AccesstothefullcontentofClinicalGastroenterologyandHepatologyOnlineisCENTERCITY,NY10001-AGAmembershaveseamlessaccesstofullClinicalGastroenterologyandHepatologycontentfromtheAGAWebsite.Simplysigninto ,visitthePublicationssectionoftheWebsite,andclickonClinicalGastroenterologyandHepatology.YouwillbedirectedtotheJournalWebsiteandwillhaveaccesstoallcontentwithouthavingtosupplyadifferentusernameandpassword.Memberscanalsovisit directlyandclickon“ActivateOnlineAccess.”NonmembersubscribersmustcreateanonlineuseraccountandactivatetheirsubscriptiontoaccessthefulltextofarticlesonClinicalGastroenterologyandHepatologyOnline.Toactivateyourindividualonlinesubscription,pleasevisit andclickon“ActivateOnlineAccess.”Toactivateyouraccount,youwill

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ClinicalGastroenterologyandHepatologyAccuracyofMagneticallyControlledCapsule ComparedWithConventionalGastroscopy,inDetectionofGastricDiseasesZhuanLiao,*XiHou,*En-QiangLin-Hu,‡,bJian-QiuSheng,§,bZhi-ZhengGe,k,bBoJiang,¶,bXiao-HuaHou,#,bJi-YongLiu,**,bZhenLi,‡Qi-YangHuang,‡Xiao-JunZhao,§NaLi,§Yun-JieGao,kYaoZhang,kJie-QiongZhou,¶Xin-YingWang,¶JunLiu,#Xiao-Xie,#Cong-MeiYang,**Hua-LinLiu,**Xiao-TianSun,*Wen-BinZou,*andZhao-ShenLi**DepartmentofGastroenterology,ChanghaiHospital,SecondMilitaryMedicalUniversity,Shanghai,China;‡DepartmentofGastroenterology,GeneralHospitalofChinesePeople’sLiberationArmy,Beijing,China;§DepartmentofGastroenterology,BeijingMilitaryGeneralHospital,Beijing,China;kDivisionofGastroenterology,RenjiHospital,SchoolofMedicine,ShanghaiJiaotongUniversity,Shanghai,China;¶DepartmentofGastroenterology,NanfangHospital,SouthernMedicalUniversity,Guangzhou,China;#DepartmentofGastroenterology,UnionHospital,TongjiMedicalCollege,HuazhongUniversityofScienceandTechnology,Wuhan,China;**DepartmentofGastroenterology,ShProvincialHospital,Jinan,ChinaBACKGROUND&AIMS:Diseasesofthestomach,includinggastriccancerandpepticulcer,arethemostcommondigestivediseases.Itisimpossibletovisualizetheentirestomachwiththepassivecapsulecurrentlyusedinpracticebecauseofthelargesizeofthegastric.Amagneticallycontrolledcapsuleendoscopy(MCE)systemhasbeendesignedtoexplorethestomach.WeperformedaprospectivestudytocomparetheaccuracyofdetectionofgastricfocallesionsbyMCEvsconventionalgastroscopy(thestandardmethod). WeperformedamulticenterblindedstudycomparingMCEwithconventionalgastroscopyin350patients(meanage,46.6y),withupperabdominalcomplaintsscheduledtoundergogastroscopyatatertiarycenterinChinafromAugust2014throughDecember2014.AllpatientsunderwentMCE,followedbyconventionalgastroscopy2hourslater,withoutsedation.Wecalculatedthesensitivity,specificity,positivepredictivevalue,andnegativepredictivevalueof interval[CI],84.7%–96.1%),94.7%specificity(95%CI,91.9%–97.5%),apositivepredictivevalueof90.6%sensitivity(95%CI,82.7%–98.4%)and97.9%specificity(95%CI,96.1%–99.7%).MCEMCEdidnotmissanylesionsofsignificance(includingtumorsorlargeulcers).Amongthe350patients,5reported9adverseevents(1.4%)and335preferredMCEovergastroscopy(95.7%). MCEdetectsfocallesionsintheupperandlowerstomachwithcomparableaccuracywithcon-ventionalgastroscopy.MCEispreferredbyalmostallpatients,comparedwithgastroscopy,andcanbeusedtoscreengastricdiseaseswithoutsedation.Clinicaltrials.number:NCT :MagneticallyControlledCapsuleEndoscopy;Gastroscopy;GastricDiseases;DiagnosticAccuracy;bAuthorsshareco-seniorauthorship. Abbreviationsusedinthispaper:CE,capsuleendoscopy;CI,confidenceinterval;CMOS,complementarymetal-oxidesemiconductor;magneticallycontrolledcapsuleendoscopy;SMT,submucosalMostcurrent

©2016bytheAGAInstitute.PublishedbyElsevierInc.ThisisanopenaccessarticleundertheCCBY-NC-NDlicense org/licenses/by-nc-1542-September MCEvsGastroscopyDiseasesofthestomach,includinggastriccancerandpepticulcer,arethemostcommondigestivediseases.Gastriccanceristhefourthmostcommoncancerglobally,andisthesecondmostcommoncauseofdeathfromcancerworldwide.1Almost4%to17%oftheworldpopulationhasorhashadapepticulcerofthestomachorduodenum.2Conventionalgastroscopyallowsfortheaccuratelocalizationoflesions,andisthemosteffectivediagnosticmodalityforgastricdiseases. y,itisinvasiveand fortableundernonsedatedsituations,leadingtolowpatientcompliance.Althoughsedationcanimprovepatientcompliance,itscosthasbeenamajorconcern,aswellas fortandanesthesia-relatedadverseeventsthatareDinafewpatientsaftertheCapsuleendoscopy(CE)wasfirstintroducedin2000,andrepresentsamorepatient-friendlyalternativemethodofexaminationwithoutsignificant whichhasbeenwidelyappliedinclinicalpractice.4,5However,completegastricvisualizationwiththepassivecapsulecurrentlyusedinclinicalpracticeisimpossiblebecauseofthelargesizeofthegastric.Recently,studieshaveshownthattheuseofcapsulesmaneuveredwithanexternalmagneticfield,so-calledmagneticallycontrolledcapsuleendoscopy(MCE),mayrepresentamorereliableapproachforgastricexamination;severaltrialshavereportedpromisingresults.6–9However,mostofthesestudieswerepilotstudieswithasmallsamplesize,andnolargemulticenterstudyhasbeenreported.AnovelMCEsystemwasdevelopedandapprovedtheChinaStateFoodandDrugAdministrationin2013,whichusesapermanentmagneticfieldgeneratedbyanexternalindustrialrobottoallowfornoninvasiveexplorationofthestomach.TwopilotstudieshaveshownthattheMCEsystemwassafeandfeasibleinhealthyvolunteersandasmallnumberofpatients.10,11However,thediagnosticaccuracyofMCEforgastricdiseasesneedstobeconfirmedinalarge-scaletrial.Therefore,thislargeprospectivemulticenterstudywasperformedtocomparetheperformanceofMCEwithconventionalgastroscopyindetectinggastriclesions.MaterialsandStudyThisstudywasaprospective,self-controlled,multi-center,blindedcomparisonstudy.Thestudyprotocolwasapprovedbytheinstitutionalreviewboardofeachparticipatingcenter.Writteninformedconsentwasobtainedfromallpatients.StudyThismulticentercomparativestudywasconductedat

tertiaryreferralcentersbetweenAugust2014andDecember2014.Adultpatientswithupperabdominalcomplaintsaged18to75years,whowerescheduledtoundergoagastroscopy,wereeligibleforthisstudy.Patientswithanyofthefollowingconditionswereexcluded:(1)dysphagiaorsymptomsofgastricoutletobstruction,sus-pectedorknownintestinalstenosis,overtgastrointestinalbleeding,historyofuppergastrointestinalsurgeryorabdominalsurgeryalteringgastrointestinalanatomy,orpostabdominalradiation;(2)congestiveheartfailure,renalinsufficiency,undertherapeuticanticoagulation,inpoorgeneralcondition(AmericanSocietyofAnesthesiologistsclassIII/IV),claustrophobia,metallicparts,apacemakerorotherimplantedelectromedicaldevices,orartificialheartvalves;(3)pregnancyor edpregnancy;(4)exclu-sioncriteriaforstandardmagneticresonanceimagingex-aminationsuchasthepresenceofsurgicalmetallicdevices,eventhoughitslowmagneticfieldtechnicallywouldnotinterferewithsuchdevices;or(5)currentlyparticipatinginanotherclinicalstudy.StudyMCEwasperformed,followedbyconventionalgastros-copy2hourslater,withoutsedationineligiblepatients.TheperformanceindetectinggastricfocallesionsbetweenMCEandconventionalgastroscopywascompared.Magneticallycontrolledcapsuleendoscopysystem.MCEsystemwasprovidedbyAnkonTechnologiesCo,(Wuhan,Shanghai,China).Thissystemconsistsanendoscopiccapsule,aguidancemagnetrobot,adatarecorder,andacomputerworkstationwithsoftwareforreal-timeviewingandcontrolling.Thecapsulehasasizeof2812mm,andcontainsapermanentmagnetinsideitsdome.Imagesarecapturedandrecordedat2frames/s(SupplementaryFigure1A).TheviewangleoftheMCEis140,andtheviewdistanceis0to60mm.ACMOSimagesensorisusedintheMCE.TheLEDlightexposuretimeandsignalgainofCMOSsensorareadjustedautomaticallybymeasuringthehistogramoftheimagetooptimizebrightnessandcontrasttheimages.TherobotusedtoguidethemagnetwasaC-armtypewith5df,2rotationaldegreesand3translationaldegrees.Thecapsulecanbecontrolledeithermanuallybyaguidancemagnetrobotthroughajoystickorautomaticallybydefaultmode.ThesizeoflesionscouldbemeasuredbytheESNavisoftware(AnkonTechnologiesCo,,Wuhan,China).RecordinganddownloadingdataaresimilartootherCEs(SupplementaryFigure1B).Gastricpreparationregimenandmagneticallycontrolledcapsuleendoscopyexaminationprotocol.Patientsarrivedatthehospitalinthemorningafterovernightfasting(>8hours).Inclinicalpractice,weusedsimethicone(MenariniGroup,Florence,Italy)asadefoamingagentto

improvegastricmucosalvisualization,andpronasegranules(BeijingTidePharmaceuticalCo,,Beijing,China)toremovegastricmucus.12–15DuringtheMCEexamination,patientswereaskedtodrink500to1000mLofwaterondemand.1268Liaoet ClinicalGastroenterologyandHepatologyVol.14,No.Whenthecapsulereachedthestomach,thecapsulewasliftedawayfromtheposteriorwall,rotated,andadvancedtothefundusandcardiacregions,andthentothegastricbody,angulus,antrum,andpylorus.Ifdistensionwasinsufficient,wateringestionwasrepeated.TheMCEgastricexaminationtimewaslimitedto30minutes.Allpatientswerefollowedupforupto2weekstoconfirmcapsuleexcretionandanyadverseevents.Thepatientswereaskedto theexcretiontimeofthecapsuleiftheyfoundthecapsuleinthestool.Ifthepatientsdidnotfoundthecapsulein2weeks,theyshouldcomebacktothecenterforconfir-mationbymagneticscanningorabdominalplainradio-graphGastricmucosalcleanlinessandvisualization.mucosalcleanlinessandvisualizationinprimaryanatomiclandmarksofthestomachincludingthecardia,fundus,body,angulus,antrum,andpylorusofthestomachwereevaluatedandscored,respectively.A4-pointgradingscalewasusedtoobjectivelydescribethecleanlinessofthestomachduringMCEasexcellent,good,fair,orpoor(SupplementaryFigure2).16,17A3-pointgradingscalewasusedtoobjectivelydescribethecompletevisualizationofthegastricmucosainthe6anatomiclandmarksinthestomach.The3-pointgradingscaledescribedthevisualizationofthegastricmucosaasgood(>90%ofthemucosawasfair(70%–90%ofthemucosawasobserved),andpoor(<70%ofthemucosawasobserved).Gastroscopy.Conventionalgastroscopysedationwasperformedbyasecondexperiencedphysicianwhowasblindedtothecapsuleresults2hoursaftercapsuleingestiononthesameday,andthiswasintroducedasthestandarddiagnosticmethodwithwhichMCEwascompared.Gastricfocallesionswerediagnosed,andtheirsizewasmeasuredbyeithervisualestimationorestimationwiththeuseofopenbiopsyforcepsduringgastroscopy.Gastricbiopsyspecimenswereobtainediftheendoscopistperformingtheexami-nationconsideredtheproceduretobeclinicallyneces-sary.IfafocallesionwasobtainedbyMCE,butnotbythesubsequentgastroscopy,asecondgastroscopywasper-formed1weekafterMCEbyaseniorendoscopist,whowasinformedofthefalse-positivefindingbyMCE.Weonlyusedthefirstgastroscopyresultforthefinaldataysis,thesecondgastroscopywasperformedonlyforensuringwhetherornottherewasafocalgastricAfterMCEandgastroscopy,allthepatientswereaskediftheypreferredMCEorgastroscopy.ThephysicianwhoperformedtheMCEandreadthereal-timegastriccapsulesandtheotherphysicianwhoperformedthegastroscopywereunawareofeachother’sfindingscompletionoftheexaminationsand

Theprimary einthepresentstudywasgastricfocallesion,whichwasdefinedasanyofthefindingsincludingpolyp,ulcers,submucosaltumor(SMT),andothers(ie,xanthoma,diverticulum,andsoforth).Erosion,gastritis,andgastricatrophyweredefinedasnegativefindingsbecausetheyarediffuselesionsthatcanbediagnosedeasilybyMCE. esincludedgastriccleanlinessandmucosalvisualizationduringMCE,patientcompliance,andsafetyofMCE. compliance,andsafetyofMCE.Selectedreadingspeedinitiallywassetandfixedat4framespersecond.EvaluationofMCEwasperformedbyawell-trainedphysicianwithexperi-enceofatleast400capsuleendoscopies.CE softhegastrointestinaltract,togetherwith softhesmallbowelifavailable,werereadand yzedcarefullyinrealtimeandaftertheprocedure.Allthefindingsintheesophagus,smallbowel,andcolonbyMCEalsowererecordedanddisclosedtopatients,butwedidnotreportthosedatainthisarticlebecauseofthespecificityoftheresearchPatientcomplianceforMCE,definedasthetolerancetoproceduresoftheMCEexaminationincludingswal-lowingofthecapsule,drinkingplentyofwater,andlyingdownforatleasthalfanhour,wasmonitored.Adverseevents,definedassymptomsorsignssuchasabdominaldistension,nausea,orvomiting,weremonitoredcloselyandrecordedbyinterviewingthepatientasanoutpa-tientorbyephone1,3,5,and7days,and2weeksaftertheMCEprocedure.Capsuleretention(ie,acapsuleendoscoperemaininginthedigestivetractforamini-mumof2weeksoracapsuleendoscopethatrequiresdirectedinterventionortherapytoaiditspassage)alsocarefullywasmonitoredandmanagedforupto Forsamplesizecalculation,consideringconventionalgastroscopyasthegoldstandard,ourstudyassumedthatgastricCEhasatleast87%sensitivityand52%specificityindetectingpatientswithgastricfocallesions,whichwereseparaythelowerlimitvaluesofthe95%confidenceinterval(CI)of96.00%sensitivityand77.78%specificityaccordingtoourpreviousstudyre-sults.11Tomaintainthathypothesis,aswellasthesig-nificancelevelof5%(2-sided)andtoleranceerrorof6%,therequiredpositivefindingswereestimatedtobe60.Inaddition,theprevalenceofgastricfocallesionswasassumedtobe20%inapopulationthatunderwentroutinegastroscopy(accordingtoanunpublished-ysisofgastroscopyresultsatChanghaiHospitalin2013).Wechose300asthestudysamplesize.Withanesti-mateddrop-outrateof15%,atotalstudysizeof345patientswasrequired.

Per-patientcomparisonsbetweenconventionalgastroscopyandMCEwereperformedaccordingtothetype,location,andsizeofthelesions.Ifmorethan1focallesionwasdetectedinapatient,themostimportantclinical-relatedfindingwiththepriorityofulcer,SMT,polyp,andotherswaschosenasthefinaldiagnosis.September MCEvsGastroscopyDescriptivestatisticsforcontinuousvariablesareexpressedasthemeanSDormedianandrangevalues,whereappropriate.Variablespertainingtoaccuracywerecalculatedwitha95%CI(normalapproximate)basedonabinomialdistribution,inwhichconventionalgastroscopywasconsideredtobethestandardproce-durefordetectingfocallesions,andgastroscopycombinedwithbiopsywasconsideredthegoldstandardprocedurefordetectingulcersandcancer.SensitivitywascalculatedasthepercentageofpatientswhohadpositivefindingsonMCE(ofaspecifiedcategory)amongthosepatientswhohadpositivefindingsongastroscopy(ofthesamecategory).SpecificitywascalculatedasthepercentageofpatientswhohadnegativefindingsonMCE(ofaspecifiedcategory)amongpatientswithnegativefindingsongastroscopy(ofthesamecategory),andthiscorrespondedto1-thefalse-positiverate.Statisticalan-alyseswereperformedwithSASsoftwareversion9.3(SASInstitute,Inc,Cary,Allauthorshadaccesstothestudydataandreviewedandapprovedthefinalmanuscript.Atotalof353patientswereenrolledin7participatingcenters.Threepatients(0.8%)refusedfurtherconventionalgastroscopyafterMCEandwerenotincludedintheysis.Therefore,350patientswhocompletedtheMCEandconventionalgastroscopywereincludedintheysis.Amongthesepatients,186(53.1%)weremaleand164(46.9%)werefemale;andthemeanagewas46.613.3years(range,18–75y).Atotalof110patients(31.4%)whowerediagnosed

withfocallesionsor/andatrophicgastritisrequiredbiopsyundergastroscopy.ThemeantimeoftheMCEstudieswas26.45.1minutes(range,20–33min). magneticallycontrolledcapsuleendoscopy.Table1showstheper-patientprevalenceofgastricfocallesionsdetectedbyconventionalgastroscopyandtheperfor-manceofMCEfordetectinglesions(Figures1and2).Forgastroscopy,121focallesionsincludingpolyp(n¼53),ulcer(n¼34),SMT(n¼19),andothers(n¼15)werefoundin104patients,whichrepresents29.7%ofthepatientsstudied;85patientshadonly1kindoffocallesionand19patientshadatleast2kindsoffocallesionsinthestomach.Varioustypesofgastritiswerepresentintheremaining246patients.Amongthe104patients,24(23.1%),27(26.0%),and53(51.0%)patientshadfocallesions(themostclinicallyrelatedlesionchosenasthefinaldiagnosis)locatedatthecardia/fundus,body,andangulus/antrum,respec-tively.Sixty-four(61.5%)patientshadlesionslessthan5mminsize,and40(38.5%)patientshadlesionsmorethan5mminsize.MCEdetected128focallesionsincludingpolyp(n¼57),ulcer(n¼32),SMT(n¼17),andothers(n¼22)in107patients.Gastritiswaspre-sentintheremaining243patients.Gastricfocallesionswereobservedin10patientsbygastroscopy,whereasgastricfocallesionswereobservedin13patientsbyMCE(Tables1and2).Performanceofmagneticallycontrolledcapsuleendos-copyindetectinggastricfocallesions.Withconventionalgastroscopyasthegoldstandard,thesensitivity,speci-ficity,positivepredictivevalue,andnegativepredictiveTable1.PrevalenceofGastricFocalLesionsDetectedbyConventionalGastroscopyandMCEin350PatientsWithUpperGastrointestinalComplaints,andthePerformanceofMCEComparedWithGastroscopy Patients,n Patients,n Sensitivity,%(95% Specificity,%(95%10410743473028Submucosal18171315Upper5154Lower5353<5647154036thefinalbIncluding3malignantulcercIncludingearlygastriccancer,xanthoma,diverticulum,venous ia,andectopicdUpperstomachincludesthecardia,fundus,andbody,andlowerstomachincludestheangulus,antrum,and1270Liaoet ClinicalGastroenterologyandHepatologyVol.14,No.Figure1.Representativepolypsobservedoncon-ventionalgastroscopyandMCE.(A–C)MCEexami-nationand(D–F)valueofMCEindetectingallgastricfocallesionswere90.4%(95%CI,84.7–96.1),94.7%(95%CI,87.9%(95%CI,81.7–94.0),and95.9%(95%93.4–98.4),respectively.Diagnosticaccuracywas(95%CI,90.83–96.02)(TableThesensitivityandspecificityofMCEindetectingfocallesionsintheupperstomach(includingthecardia,fundus,andbody)were90.2%(95%CI,82.0–98.4)and96.7%(95%CI,94.4–98.9),respectively;whereasthesensitivityandspecificityofMCEindetectingfocalle-sionsinthelowerstomach(includingtheangulus,antrum,andpylorus)were90.6%(95%CI,82.7–98.4)and97.9%(95%CI,96.1–99.7),respectively.ThesensitivityandspecificityofMCEindetectingfocalle-sionslessthan5mmwere92.2%(95%CI,85.6–98.8)

and95.1%(95%CI,92.4–97.8),respectively;andthesensitivityandspecificityofMCEindetectingfocalle-sionsthatare5mmorlargerwere87.5%(95%CI,97.8)and99.6%(95%CI,97.6–99.9),(TableLargegastriculcers(>10mm)weredetectedbyconventionalgastroscopyin3cases;wherein2werediagnosedwithmalignantlymphomaand1wasdiag-nosedwithgastriccancerbypathologicexamination.UlcersalsoweredetectedbyMC

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