1、Trauma Project23 March 2005 Milan, Italy“Trauma Project:Results”Daniela Bokor MDImaging Guided & Integrated Technology (IGIT) Bracco Imaging S.p.A.- Milan, ItalyClinical SitesOspedale “Valduce”, Como, Italy- CENTER #01p.i. Dr. Martegani (study coordinator) & Dr. AianiOspedale Maggiore, Bologna, Ital

2、y - CENTER #02p.i. Dr. Ziosi & Dr. MontanariKings College Hospital, London, United Kingdom - CENTER #03p.i. Dr. Sidhu & Dr. ThompsonOspedale S.Orsola, Bologna, Italy - CENTER #04p.i. Prof. Barozzi & Dr. ValentinoCentro Traumatologico Ortopedico, Turin, Italy - CENTER #05p.i. Prof. Faletti & Dr. De M

3、archiOspedale S.Maria delle Grazie, Pozzuoli, Italy - CENTER #06p.i. Prof. Siani & Dr. CatalanoObjectives of the StudyTheobjectiveofthestudywastoevaluatebothandthetheconventionalB-ModeultrasoundCnTIexamination(2.4mL2,SonoVue-enhancedbolusinjection) versus Contrast Enhanced CT modality and/orSurgery

4、and/or Angiography as reference standards inthedetection/exclusionofpost-traumaticabdominalinjuriesStudy DesignImaging Procedures :Ultrasonography was performed using commerciallyavailable EsaoteImaging,(CnTI)equipmentwithContrastTunedandATL5000equipment with Pulse Inversion (PI).Baseline examinatio

5、nAcompleteunenhancedabdominalultrasoundevaluationwasperformed, using any US modality available, in order to obtain the best diagnostic information possible to demonstrate presence/absence of traumatic lesions.Attention was given to pericardial space, hepato-renal, spleno-renal and pelvic spaces, to

6、look for free fluid and any suggestion of solidorgan injury.Study Design , contdSonoVue Enhanced Ultrasonography:A complete contrast enhanced abdominal ultrasound evaluation was performed using CnTI and PI modality. Each patient received up to 2bolus injections of SonoVue (2.4 mL 2).In order to have

7、 a complete evaluation of the main abdominal organs(liver, kidneys, spleen) the following procedure was followed: During first bolus injection one of the kidney was evaluated. At the end of the kidney evaluation a first assessment of liver and spleen parenchyma was performed. The same procedure was

8、repeated during second bolus injection ofSonoVue. In this case the other kidney was assessed.Study Design, contdReference Methods:Contrast enhanced spiral CTA complete evaluation of the area of suspected trauma wasperformed, within one hour from the ultrasound examinationsIn few cases CT examination

9、 was not performed, and thereference standard was SurgeryIn case of vascular trauma an Angiography examination wasalso performedInclusion CriteriaPatients of either sex:14 years or olderwith suspicion of post traumatic abdominal lesion(s)referredtoemergencyroomfordetectingorexcludingposttraumatic le

10、sionswithCECTimages(ifnecessarysurgicalexamination)ofthetraumatized area within one hour of the ultrasound examinations Giving written informed consent to participate in the study. In case ofminorsorpatientwithreducedlevelofconsciousnessatthe moment of hospital admittance a legal tutor will be requi

11、red to givewritten informed consentCriteria of EfficacyPresence/absence of abdominal trauma in kidneys, liver,spleenand vascular Vs. contrast enhanced CT and/orSurgery and/or Angiography (reference standards)Lesion description in comparison to reference standardsin terms of :No trauma ContusionHaema

12、toma Bleeding Laceration RuptureDefinitionsTP 100SENSITIVITY =TP + FNTN 100SPECIFICITY =TN + FPTP + TN 100ACCURACY =All subjects testedResultsDemographic Results156 patients with abdominal trauma were enrolled in the study118 male and 38 femaleMean age: 39 yrs (range 15-90 yrs)Injuries Severity Scor

13、e (ISS)*: 0 to 50Revised Trauma Score (RTS)*:1.96 to 7.84*ISS = anatomical scoring system that provides an overall score for patients with multiple injuries. Each injury is assigned an Abbreviated Injury Scale (AIS) score and is allocated to one of six body regions (head, face,chest, abdomen, extrem

14、ities including pelvis, external)* RTS = 0.9368 GCS + 0.7326 SBP + 0.2908 x RRwhere GCS = Glasgow Coma ScoreSBP = Systolic Blood PressureRR = Respiratory RateTrauma Description per Patient 64 patients had no abdominal lesions 78 patients had one abdominal lesions 12 patients had two abdominal lesion

15、s 1 patient had more than three abdominal lesionsTrauma Distribution per Organ(Reference Standard)LesionsNumberPseudoAneurismParenchymal OrganHaematomaBleedingRuptureOtherKIDNEY261237-7LIVER3813515110SPLEEN4313116-19TOTAL10738938136Trauma Distribution per Organ(SonoVue-enhanced CnTI)LesionsNumberPse

16、udoAneurismParenchymal OrganHaematomaBleedingRuptureOtherKIDNEY19916-6LIVER3312116-7SPLEEN4112116-18TOTAL9333338-31Trauma Distribution per Organ(Fundamental US)LesionsNumberPseudoAneurismParenchymal OrganHaematomaBleedingRuptureOtherKIDNEY12613-2LIVER291527-6SPLEEN371427-17TOTAL7835517-25Reference S

17、tandardAll the 156 patients had a reference standardPatients with CT: 151 Patients with only Surgery: 5Patients with more reference standard: 21 Patients with CT and Surgery: 17Patients with CT and Angiography: 3Patients with CT and Angiography and Surgery: 1Analysis per OrganLEFT KIDNEYBaselineCnTI

18、ReferenceFrequencyBaseline Vs ReferenceCnTIVs ReferenceNo traumaNo traumaNo trauma145TNTNNo traumaNo traumaSubcapsular capsula1FNFNNo traumaNo traumableeding1FNFNNo traumaNo traumaHaematoma1FNFNNo traumaRuptureRupture2FNTPNo traumaHaematomaHaematoma1FNTPNo traumaHaematoma + lacerationHaematoma + lac

19、eration1FNTPLacerationLacerationLaceration1TPTPRuptureRuptureRupture1TPTPRuptureHaematomaHaematoma1FPTPHaematomaNo traumaNo trauma1FPTN156LEFT KIDNEYBasal Vs ReferenceCnTI Vs ReferenceTN 135 (146)FN 7FP 2TP 2 (10)Sensitivity 22.2%Specificity 98.6%TN 146 (146)FN 3FP 7TP 7 (10)Sensitivity 70.0%Specifi

20、city 100%Accuracy: 98.1%Accuracy:87.8%RIGHT KIDNEYBaselineCnTIReferenceFrequencyBaseline Vs RSCnTI Vs RSNo traumaNo traumaNo trauma138TNTNNo traumaNo traumaInfarct1FNFNNo traumaNo traumaBleeding + Rupture1FNFNNo traumaNo traumaHaematoma3FNFNNo traumaIschaemia/ContusionIschaemia / Contusion3FNTPNo tr

21、aumaHaematomaHaematoma2FNTPContusionContusionNo trauma1FPFPRuptureBleeding + RuptureBleeding + Rupture1TPTPBleedingRuptureRupture1FPTPHaematomaNo traumaNo trauma1FPTNHaematomaHaematomaHaematoma3TPTPHaematomaHaematoma + RuptureRupture1FPTP156RIGHT KIDNEYBasal Vs ReferenceCnTI Vs ReferenceTN 138FN 10F

22、P 4TP 4 (16)Sensitivity: 28.6%Specificity: 97.2%TN 139 (140)FN 5FP 1TP 11 (16)Sensitivity: 68.7%Specificity: 99.3%(140)Accuracy:91.0%Accuracy:96.2%LIVERBaselineCnTIReferenceFrequencyBaselineVs RSCnTIVs RSNo traumaNo traumaNo trauma114TNTNNo traumaNo traumaLaceration / Contusion3FNFNNo traumaNo traum

23、aHaematoma2FNFNNo traumalacerationNo trauma1TNFPNo traumaRuptureRupture2FNTPNo traumaHaematomaHaematoma5FNTPLacerationNo traumaHaematoma1TPFNContusion / LacerationLacerationLaceration4TPTPContusionBleeding + RuptureBleeding + Rupture1FNTPRuptureRuptureRupture6TPTPBleedingNo traumaNo trauma1FPTNBleed

24、+ ruptureRuptureBleeding + Rupture1TPTPHaematomaNo traumaNo trauma2FPTNHaematomaAdenomaAdenoma2FNTPLIVER contdBaselineCnTIReferenceFrequencyBaseline Vs RSCnTI Vs RSHaematomaRuptureRupture2FNTPHaematomaRuptureRupture + Contusion1FNTPHaematomaruptureBleeding1FNFNHaematomaHaematomaBleeding + Rupture1FN

25、FNHaematomaHaematomaHaematoma4TPTPHaematomaHaematoma + RuptureBleed + Rupture1FNTPHaematomaHaematoma + RuptureHaematoma1TPFP156LIVERBaseline Vs ReferenceCnTI Vs ReferenceTN 115 (118)FN 21FP 3TP 17 (38)Sensitivity 44.7%Specificity 94.7%Accuracy: 84.6%TN 117 (118)FN 8FP 2TP 29 (38)Sensitivity 78.3%Spe

26、cificity 98.3%Accuracy: 93.6%SPLEENBaselineCnTIReferenceFrequencyBaseline Vs RSCnTI Vs RSNo traumaNo traumaNo trauma109TNTNNo traumaNo traumaBleeding + Rupture1FNFNNo traumaNo traumaHaematoma1FNFNNo traumaLacerationLaceration2FNTPNo traumaRuptureRupture7FNTPNo traumaRupture + Focal NeoplasiaRupture

27、+ Focal Neoplasia1FNTPNo traumaHaematomaHaematoma3FPTPEffusionNo traumaNo trauma1FPTNLacerationLacerationLaceration11TPTPFluidLacerationLaceration1FNTPPerisplenic fluidEffusionLaceration1FNFNInhomogeneousRuptureRupture1FNTPSub capsular HaematomaRupture + sub capsular haematomaRupture + sub capsular

28、haematoma1FNTPBleedingBleeding + RuptureHaematoma1FPFPSPLEEN contdBaselineCnTIReferenceFrequencyBaseline Vs RSCnTI Vs RSBleedingHaematomaHaematoma1TPTPHaematomaNo traumaNo trauma3FPTNHaematomaRuptureRupture3FNTPHaematomaHaematomaPossible infarct1FNFNHaematomaHaematomaHaematoma4TPTPHaematomaHaematoma

29、 + RuptureHaematoma + Rupture2FNTPHaematoma +LacerationHaematoma +LacerationLaceration1TPTP156SPLEENBaseline Vs ReferenceCnTI Vs ReferenceTN 109 (113)FN 22FP 8TP 16 (43)Sensitivity 66.7%Specificity 83.2%TN 113 (113)FN 4FP 1TP 38 (43)Sensitivity 90.5%Specificity 96.6%Accuracy:80.1%Accuracy:96.8%VASCU

30、LARBaselineCnTIReferenceFrequencyNo traumaNo traumaNo trauma153No traumaNo traumaRupture1No traumaNo traumaBleeding1No traumaNo traumaHaematoma1156Analysis per PatientAbdominal Diagnostic Accuracy per PatientBaseline VS Reference FN 54FP 12TN 58TP 32Sensibility: 37.2%Specificity: 82.9%CnTI Vs ReferenceFN 15FP2TN 62TP 77Sensibility: 83.7%Specificity: 96.9%Accuracy: 89.1%Accuracy:57.7%Confidence in DiagnosisThe evaluation was performed using a s