Ultraschall Med 2021; 42(03): 270-277
DOI: 10.1055/a-1345-3626
Guidelines & Recommendations

European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB): An Update on the Pediatric CEUS Registry on Behalf of the “EFSUMB Pediatric CEUS Registry Working Group”

Register der Europäischen Ultraschallgesellschaft (EFSUMB): Update „Anwendung des kontrastverstärkten Ultraschalls bei Kindern“
1   Department Allgemeine Innere Medizin (DAIM), Kliniken Hirslanden Beau Site, Salem und Permanence, Bern, Switzerland
2   Department of Internal Medicine 2, Caritas-Krankenhaus Bad Mergentheim, Germany
3   Johann Wolfgang Goethe University Hospital, Frankfurt/Main, Germany
,
Rasa Augustiniene
4   Department of Radiology, Children’s Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos, Lithuania
,
Tomasz Batko
5   Department of Pediatric, Haematology and Oncology, Medical University of Gdansk, Poland
,
Vito Cantisani
6   Radiological, Oncological and Anatomy-Pathological Sciences University Sapienza of Rome, Italy
,
Andrius Cekuolis
4   Department of Radiology, Children’s Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos, Lithuania
,
Annamaria Deganello
7   Department of Radiology, King’s College London, King’s College Hospital, United Kingdom of Great Britain and Northern Ireland
,
Yi Dong
8   Department of Ultrasound, Zhongshan Hospital, Fudan University, Shanghai, China
,
Doris Franke
9   Department of Pediatric Kidney, Liver and Metabolic Diseases, Hannover Medical School, Hannover, Germany
,
Zoltan Harkanyi
10   Department of Radiology, Heim Pal National Pediatric Institute, Budapest, Hungary
,
Paul D. Humphries
11   Great Ormond Street Hospital for Children and University College London NHS Foundation Trusts
,
Maciej Jędrzejczyk
12   Ultrasound Diagnostic Department, Faculty of Medical Sciences, Medical University of Warsaw, Poland
,
Jörg Jüngert
13   Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany
,
Horst Kinkel
14   Krankenhaus Düren, Klinik für Gastroenterologie, Hepatologie, Diabetologie und Intensivmedizin, Düren, Germany
,
Orsolya Koller
10   Department of Radiology, Heim Pal National Pediatric Institute, Budapest, Hungary
,
Wojciech Kosiak
15   Ultrasound and Biopsy Diagnostics Lab at the Clinic of Pediatrics, Haematology and Oncology, Medical University of Gdansk, Poland
,
Christian Kunze
16   Clinic and Policlinic of Radiology, University Medical Center Halle (Saale), Germany
,
Anoushka Ljutikov
17   Department of Diagnostic Imaging, Barts Health NHS Trust, The Royal London Hospital, London, United Kingdom
,
Jaroslaw Madzik
18   Institute of Mother and Child, Department of Diagnostic Imaging, Warsaw, Poland
,
Hans-Joachim Mentzel
19   Section of Pediatric Radiology, Institute of Diagnostic and Interventional Radiology. University Hospital Jena, Germany
,
20   Department of Radiology, Medical University of Gdansk, Poland
,
7   Department of Radiology, King’s College London, King’s College Hospital, United Kingdom of Great Britain and Northern Ireland
,
Dagmar Schreiber-Dietrich
21   Localinomed, Bern Switzerland
22   Department of Pediatric Medicine, Caritas-Krankenhaus Bad Mergentheim, Germany
,
Maria E. Sellars
7   Department of Radiology, King’s College London, King’s College Hospital, United Kingdom of Great Britain and Northern Ireland
,
Martin Stenzel
23   Kliniken der Stadt Köln gGmbH, Kinderradiologie, Köln, Germany
,
Heike Taut
24   Children’s Hospital, Universitätsklinikum Dresden, Technische Universität Dresden, Dresden, Germany
,
Gibran T. Yusuf
7   Department of Radiology, King’s College London, King’s College Hospital, United Kingdom of Great Britain and Northern Ireland
,
7   Department of Radiology, King’s College London, King’s College Hospital, United Kingdom of Great Britain and Northern Ireland
› Author Affiliations

Abstract

The European Federation of Ultrasound in Medicine and Biology (EFSUMB) created the “EFSUMB Pediatric Registry” (EFSUMB EPR) with the purpose of collecting data regarding the intravenous application of pediatric contrast-enhanced ultrasound (CEUS). The primary aim was to document the current clinical practice and usefulness of the technique and secondarily to assess CEUS safety in children. We issue the preliminary results of this database and examine the overall practice of CEUS in children in Europe.

Zusammenfassung

Die Europäische Ultraschallgesellschaft (EFSUMB) initiierte eine Datensammlung zum pädiatrischen kontrastverstärkten Ultraschall. Die Ziele waren es, für die intravenöse Untersuchungstechnik Anwendungsmöglichkeiten und Technik zu dokumentieren sowie das Sicherheitsprofil bei Kindern zu reflektieren. Wir präsentieren hiermit die Ergebnisse für die Anwendung des kontrastverstärkten Ultraschalls in Europa.



Publication History

Received: 06 October 2020

Accepted: 24 December 2020

Article published online:
09 March 2021

© 2021. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 
  • References

  • 1 Starkey E, Sammons HM. Sedation for radiological imaging. Arch Dis Child Educ Pract Ed 2011; 96: 101
  • 2 Sammons HM, Edwards J, Rushby R. et al. General anaesthesia or sedation for paediatric neuroimaging: current practice in a teaching hospital. Archives of Disease in Childhood 2011; 96: 114
  • 3 Guzel A, Atli A, Dogan E. et al. Magnetic resonance imaging in children under anesthesia: the relationship between the degree of information provided to parents and parents’ anxiety scores. Biomed Res Int 2014; 2014/05/25: 425107
  • 4 Voepel-Lewis T, Tait AR, Malviya S. Separation and induction behaviors in children: Are parents good predictors?. Journal of PeriAnesthesia Nursing 2000; 15: 6-11
  • 5 Malviya S, Voepel-Lewis T, Prochaska G. et al. Prolonged recovery and delayed side effects of sedation for diagnostic imaging studies in children. Pediatrics 2000; 105: E42
  • 6 Malviya S, Voepel-Lewis T, Tait AR. et al. Sedation/analgesia for diagnostic and therapeutic procedures in children. Journal of PeriAnesthesia Nursing 2000; 15: 415-422
  • 7 Katayama H, Yamaguchi K, Kozuka T. et al. Adverse reactions to ionic and nonionic contrast media: A report from the Japanese Committee on the Safety of Contrast Media. Radiology 1990; 175: 621-628
  • 8 Hunt CH, Hartman RP, Hesley GK. Frequency and Severity of Adverse Effects of Iodinated and Gadolinium Contrast Materials: Retrospective Review of 456930 Doses. Am J Roentgenol 2009; 193: 1124-1127
  • 9 Dillman JR, Ellis JH, Cohan RH. et al. Frequency and Severity of Acute Allergic-Like Reactions to Gadolinium-Containing IV Contrast Media in Children and Adults. Am J Roentgenol 2007; 189: 1533-1538
  • 10 Kanal E, Tweedle MF. Residual or Retained Gadolinium: Practical Implications for Radiologists and Our Patients. Radiology 2015; 275: 630-634
  • 11 Elbeshlawi I, AbdelBaki MS. Safety of Gadolinium Administration in Children. Pediatric Neurology 2018; 86: 27-32
  • 12 Donnelly LF. Reducing Radiation Dose Associated with Pediatric CT by Decreasing Unnecessary Examinations. Am J Roentgenol 2005; 184: 655-657
  • 13 Brenner DJ, Hall EJ. Computed Tomography – an increasing source of radiation exposure. N Engl J Med 2007; 357: 2277-2284
  • 14 Brenner DJ, Hall EJ. Cancer risks from CT scans: now we have data, what next?. Radiology 2012; 265: 330-331
  • 15 Brenner DJ, Elliston C, Hall EJ. et al. Estimated risks of radiation-induced fatal cancer from pediatric CT. Am J Roentgenol 2001; 176: 289-296
  • 16 Pearce MS, Salotti JA, Little MP. et al. Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospective cohort study. Lancet 2012; 380: 499-505
  • 17 Muhogora WE, Ahmed NA, AlSuwaidi JS. et al. Paediatric CT examinations in 19 developing countries: frequency and radiation dose. Radiation Protection Dosimetry 2010; 140: 49-58
  • 18 Sidhu PS, Cantisani V, Deganello A. et al. Role of contrast-enhanced ultrasound (CEUS) in paediatric practice: An EFSUMB position statement. Ultraschall in Med 2017; 38: 33-43
  • 19 Back SJ, Maya C, Darge K. et al. Pediatric contrast-enhanced ultrasound in the United States: a survey by the Contrast-Enhanced Ultrasound Task Force of the Society for Pediatric Radiology. Pediatric Radiology 2018; 48: 852-857
  • 20 Darge K. Voiding urosonography with US contrast agent for the diagnosis of vesicoureteric reflux in children: an update. Pediatric Radiology 2010; 40: 956-962
  • 21 Sellars ME, Deganello A, Sidhu PS. Paediatric contrast-enhanced ultrasound (CEUS); a technique that requires co-operation for rapid implementation into clinical practice. Ultraschall in Med 2014; 35: 203-206
  • 22 Piskunowicz M, Kosiak W, Irga N. Why can’t we use second generation ultrasound contrast agents for the examination of children?. Ultraschall in Med 2011; 32: 83-86
  • 23 Piskunowicz M, Kosiak W, Batko T. Intravenous application of second-generation ultrasound contrast agents in children: a review of the literature. Ultraschall in Med 2012; 33: 135-140
  • 24 Food & Drug Administration. MARCH 2016 – APPROVED DRUG PRODUCT LIST. 2016 http://www.fda.gov/downloads/drugs/developmentapprovalprocess/ucm071120.pdf
  • 25 Bazzano ATF, Mangione-Smith R, Schonlau M. et al. Off-Label Prescribing to Children in the United States Outpatient Setting. Academic Pediatrics 2009; 9: 81-88
  • 26 Knopf H, Wolf IK, Sarganas G. et al. Off-label medicine use in children and adolescents: results of a population-based study in Germany. BMC Public Health 2013; 13: 631
  • 27 Pandolfini C, Bonati M. A literature review on off label drug use in children. Eur J Pediatr 2005; 164: 552-558
  • 28 Riccabona M. Application of a second-generation US contrast agent in infants and children – a European questionnaire-based survey. Pediatr Radiol 2012; 42: 1471-1480
  • 29 Rosado E, Riccabona M. Off-label use of ultrasound contrast agents for intravenous applications in children. Analysis of the existing literature. J Ultrasound Med 2016; 35: e21-e30
  • 30 Jenssen C, Gilja OH, Serra AL. et al. European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) Policy Document Development Strategy: Clinical Practice Guidelines, Position Statements and Technological Reviews. Ultrasound Int Open 2019; 05: E2-E10
  • 31 Riccabona M, Vivier PH, Ntoulia A. et al. ESPR uroradiology task force imaging recommendations in paediatric uroradiology, part VII: standardised terminology, impact of existing recommendations, and update on contrast-enhanced ultrasound of the paediatric urogenital tract. Pediatr Radiol 2014; 44: 1478-1484
  • 32 Riccabona M, Avni FE, Damasio MB. et al. ESPR Uroradiology Task Force and ESUR Paediatric Working Group – Imaging recommendations in paediatric uroradiology, Part V: childhood cystic kidney disease, childhood renal transplantation and contrast-enhanced ultrasonography in children. Pediatr Radiol 2012; 42: 1275-1283
  • 33 Harkanyi Z. Potential applications of contrast-enhanced ultrasound in pediatric patients. Ultrasound Clin North Am 2013; 8: 403-422
  • 34 Deganello A, Rafailidis V, Sellars ME. et al. Intravenous and Intracavitary Use of Contrast-Enhanced Ultrasound in the Evaluation and Management of Complicated Pediatric Pneumonia. J Ultrasound Med 2017; 36: 1943-1954
  • 35 Berry JD, Sidhu PS. Microbubble contrast-enhanced ultrasound in liver transplantation. Eur Radiol 2004; 14: P96-P103
  • 36 Bonini G, Pezzotta G, Morzenti C. et al. Contrast-enhanced ultrasound with SonoVue in the evaluation of postoperative complications in pediatric liver transplant recipients. J Ultrasound 2007; 10: 99-106
  • 37 Sidhu PS, Shaw AS, Ellis SM. et al. Microbubble ultrasound contrast in the assessment of hepatic artery patency following liver transplantation: role in reducing frequency of hepatic artery arteriography. Eur Radiol 2004; 14: 21-30
  • 38 Torres A, Koskinen SK, Gjertsen H. et al. Contrast-Enhanced Ultrasound for identifying circulatory complications after liver transplants in children. Pediatr Transplant 2019; 23: e13327
  • 39 Al Bunni F, Deganello A, Sellars ME. et al. Contrast-enhanced ultrasound (CEUS) appearances of an adrenal phaeochromocytoma in a child with Von Hippel-Lindau disease. J Ultrasound 2014; 17: 307-311
  • 40 Rafailidis V, Deganello A, Sellars ME. et al. Pediatric adrenal trauma: evaluation and follow-up with contrast-enhanced ultrasound (CEUS). J Ultrasound 2017; 20: 325-331
  • 41 Pecere S, Holleran G, Ainora ME. et al. Usefulness of contrast-enhanced ultrasound (CEUS) in Inflammatory Bowel Disease (IBD). Digestive and Liver Disease 2018; 50: 761-767
  • 42 Chiorean L, Schreiber-Dietrich D, Braden B. et al. Ultrasonographic imaging of inflammatory bowel disease in pediatric patients. World J Gastroenterol 2015; 21: 5231-5241
  • 43 Patel K, Sellars ME, Clarke JL. et al. Features of testicular epidermoid cysts on contrast enhanced ultrasound and real time elastography. J Ultrasound Med 2012; 31: 1115-1122
  • 44 Rojas-Mirquez JC, Rodriguez-Zuniga MJM, Bonilla-Escobar FJ. et al. Nocebo effect in randomized clinical trials of antidepressants in children and adolescents: systematic review and meta-analysis. Front Behav Neurosci 2014; 8: 375
  • 45 Pan Y, Kinitz T, Stapic M. et al. Minimizing Drug Adverse Events by Informing About the Nocebo Effect-An Experimental Study. Front Psychiatry 2019; 10: 504
  • 46 Brown SGA. Clinical features and severity grading of anaphylaxis. Journal of Allergy and Clinical Immunology 2004; 114: 371-376
  • 47 Bracco. Lumason Prescribing Information. 2016 http://imaging.bracco.com/sites/braccoimaging.com/files/technica_sheet_pdf/US-20160330-LUMASON-PI_0.pdf
  • 48 Sidhu PS, Choi BI, Bachmann Nielsen M. The EFSUMB guidelines and recommendations on the clinical practice of contrast enhanced ultrasound (CEUS): a new dawn for the escalating use of this ubiquitous technique. Ultraschall in Med 2012; 32: 5-7
  • 49 Seitz K, Strobel D. A Milestone: Approval of CEUS for Diagnostic Liver Imaging in Adults and Children in the USA. Ultraschall in Med 2016; 37: 229-232
  • 50 Schreiber-Dietrich DG, Cui XW, Piscaglia F. et al. Contrast Enhanced Ultrasound in Pediatric Patients: A Real Challenge. Z Gastroenterol 2014; 52: 1178-1184
  • 51 Jacob J, Deganello A, Sellars ME. et al. Contrast Enhanced Ultrasound (CEUS) Characterization of Grey-scale Sonographic Indeterminate Focal Liver Lesions in Paediatric Practice. Ultraschall in Med 2013; 34: 529-540
  • 52 Yusuf GT, Sellars ME, Huang DY. et al. Cortical Necrosis Secondary to Trauma in a Child: Contrast-enhanced ultrasound comparable to Magnetic Resonance Imaging. Pediatr Radiol 2014; 44: 484-487
  • 53 Yusuf GT, Sellars ME, Deganello A. et al. Retrospective Analysis of the Safety and Cost Implications of Pediatric Contrast-Enhanced Ultrasound at a Single Center. Am J Roentgenol 2016; 208: 446-452
  • 54 Stenzel M. Intravenous contrast-enhanced sonography in children and adolescents – a single center experience. J Ultrason 2013; 13: 133-144
  • 55 Knieling F, Strobel D, Rompel O. et al. Spectrum, Applicability and Diagnostic Capacity of Contrast-Enhanced Ultrasound in Pediatric Patients and Young Adults after Intravenous Application – A Retrospective Trial. Ultraschall in Med 2016; 37: 1-8
  • 56 McCarville MB, Kaste SC, Hoffer FA. et al. Contrast-enhanced sonography of malignant pediatric abdominal and pelvic solid tumors: preliminary safety and feasibility data. Pediatr Radiol 2012; 42: 824-833
  • 57 McCarville MB, Coleman JL, Guo J. et al. Use of Quantitative Dynamic Contrast-Enhanced Ultrasound to Assess Response to Antiangiogenic Therapy in Children and Adolescents With Solid Malignancies: A Pilot Study. Am J Roentgenol 2016; 206: 933-939
  • 58 Menichini G, Sessa B, Trinci M. et al. Accuracy of contrast-enhanced ultrasound (CEUS) in the identification and characterization of traumatic soild organ lesionsin children: a retrospective comparison with baseline US and CEMDCT. Radiol Med 2015; 120: 989-1001
  • 59 Valentino M, Serra C, Zironi G. et al. Blunt Abdominal Trauma: Emergency Contrast-Enhanced Sonography for Detection of Solid Organ Injuries. Am J Roentgenol 2006; 186: 1361-1367
  • 60 Durkin N, Deganello A, Sellars ME. et al. Post-traumatic liver and spleen pseudoaneurysms in children: diagnosis, management and follow-up screening using contrast enhanced ultrasound (CEUS). J Pediat Surg 2016; 51: 289-292
  • 61 Piscaglia F, Bolondi L. The safety of SonoVue in abdominal applications: retrospective analysis of 23188 investigations. Ultrasound in Med Biol 2006; 32: 1369-1375
  • 62 Tang C, Fang K, Guo Y. et al. Safety of Sulfur Hexafluoride Microbubbles in Sonography of Abdominal and Superficial Organs: Retrospective Analysis of 30222 Cases. J Ultrasound Med 2017; 36: 531-538
  • 63 Coleman JL, Navid F, Furman WL. et al. Safety of ultrasound contrast agents in the pediatric oncologic population: a single-institution experience. Am J Roentgenol 2014; 202: 966-970
  • 64 Piskunowicz M, Kosiak W, Batko T. et al. Safety of intravenous application of second generation ultrasound contrast agent in children: prospective analysis. Ultrasound Med Biol 2015; 41: 1095-1099
  • 65 Torres A, Koskinen SK, Gjertsen H. et al. Contrast-enhanced ultrasound using sulfur hexafluoride is safe in the pediatric setting. Acta Radiologica 2017; 58: 1395-1399
  • 66 Mao M, Xia B, Chen W. et al. The Safety and Effectiveness of Intravenous Contrast-Enhanced Sonography in Chinese Children-A Single Center and Prospective Study in China. Front Pharmacol 2019; 10: 1447
  • 67 Claudon M, Cosgrove D, Albrecht T. et al. Guidelines and good clinical practice recommendations for contrast enhanced ultrasound (CEUS) – update 2008. Ultraschall in Med 2008; 29: 28-44
  • 68 Piscaglia F, Nolsoe C, Dietrich C. et al. The EFSUMB Guidelines and Recommendations on the Clinical Practice of Contrast Enhanced Ultrasound (CEUS). Update 2011 on non-hepatic applications. Ultraschall in Med 2012; 1: 11-12
  • 69 Sidhu PS, Cantisani V, Dietrich CF. et al. The EFSUMB Guidelines and Recommendations for the Clinical Practice of Contrast-Enhanced Ultrasound (CEUS) in Non-Hepatic Applications: Update 2017 (Long Version). Ultraschall in Med 2018; 39: e2-e44
  • 70 European Medicines Agency. SonaVue. Summary of product characteristics, 25 May 2018. https://www.ema.europa.eu/en/documents/product-information/sonovue-epar-product-information_en.pdf . Accessed December 9, 2019. EMA 2018
  • 71 Wang CL, Cohan RH, Ellis JH. et al. Frequency, outcome, and appropriatness of treatment of nonionic iodinated contrast media reactions. Am J Roentgenol 2008; 191: 409-415
  • 72 Kozma GT, Shimizu T, Ishida T. et al Anti-PEG antibodies: Properties, formation, testing and role in adverse immune reactions to PEGylated nano-biopharmaceuticals. Advanced Drug Delivery Reviews 2020
  • 73 Szebeni J. Complement activation-related pseudoallergy caused by amphiphilic drug carriers: the role of lipoproteins. Curr Drug Deliv 2005; 2: 443-449
  • 74 Szebeni J. Complement activation-related pseudoallergy: a stress reaction in blood triggered by nanomedicines and biologicals. Mol Immunol 2014; 61: 163-173
  • 75 Anupindi SA, Biko DM, Ntoulia A. et al. Contrast-enhanced US assessment of focal liver lesions in children. Radiographics 2017; 37: 1632-1647
  • 76 Fang C, Bernardo S, Sellars ME. et al. Contrast-enhanced ultrasound in the diagnosis of pediatric focal nodular hyperplasia and hepatic adenoma: interobserver reliability. Pediatric Radiology 2019; 49: 82-90
  • 77 Dietrich CF, Nolsoe CP, Barr RG. et al. Guidelines and Good Clinical Practice Recommendations for Contrast-Enhanced Ultrasound (CEUS) in the Liver–Update 2020 WFUMB in Cooperation with EFSUMB, AFSUMB, AIUM, and FLAUS. Ultrasound in Medicine & Biology 2020; 46: 2579-2604
  • 78 Dietrich CF, Nolsoe CP, Barr RG. et al Guidelines and Good Clinical Practice Recommendations for Contrast Enhanced Ultrasound (CEUS) in the Liver – Update 2020 – WFUMB in Cooperation with EFSUMB, AFSUMB, AIUM, and FLAUS. Ultraschall in Med 2020 41: 562-585
  • 79 Catalano O, Aiani L, Barozzi L. et al. CEUS in abdominal trauma: multi-center study. Abdominal Imaging 2009; 34: 225-234
  • 80 Valentino M, Serra C, Pavlica P. et al. Blunt Abdominal Trauma: Diagnostic Performance of Contrast-enhanced US in Children. IInitial Experience. Radiology 2008; 246: 903-909
  • 81 Miele V, Buffa V, Stasolla A. et al. Contrast enhanced ultrasound with second generation contrast agent in traumatic liver lesions. Radiol Med 2004; 108: 82-91
  • 82 Makin E, Durkin N, Deganello AM. et al. Reply to letter to the editor. Journal of Pediatric Surgery 2017; 52: 368-369
  • 83 Kljucevsek D, Vidmar D, Urlep D. et al. Dynamic contrast-enhanced ultrasound of the bowel wall with quantitative assessment of Crohn’s disease activity in childhood. Radiol Oncol 2016; 50: 347-354
  • 84 Sidhu PS, Cantisani V, Deganello A. et al. Authors Reply to Letter: Role of Contrast-Enhanced Ultrasound (CEUS) in Paediatric Practice: An EFSUMB Position Statement. Ultraschall in Med 2017; 38: 447-448