Clinical trial NCT04380493 - References

Chronic Liver Disease — The Use of the Transient Elastography Paediatric Probe, Compared to the M Probe, Indirect Biomarkers and Histology

Citation(s)

•   Alkhouri N, Sedki E, Alisi A, Lopez R, Pinzani M, Feldstein AE, Nobili V
  Combined paediatric NAFLD fibrosis index and transient elastography to predict clinically significant fibrosis in children with fatty liver disease. Liver Int. 2013 Jan;33(1):79-85. doi: 10.1111/liv.12024. Epub 2012 Nov 12.
•   Andersen SB, Ewertsen C, Carlsen JF, Henriksen BM, Nielsen MB
  Ultrasound Elastography Is Useful for Evaluation of Liver Fibrosis in Children-A Systematic Review. J Pediatr Gastroenterol Nutr. 2016 Oct;63(4):389-99. doi: 10.1097/MPG.0000000000001171. Review.
•   Bamber J, Cosgrove D, Dietrich CF, Fromageau J, Bojunga J, Calliada F, Cantisani V, Correas JM, D'Onofrio M, Drakonaki EE, Fink M, Friedrich-Rust M, Gilja OH, Havre RF, Jenssen C, Klauser AS, Ohlinger R, Saftoiu A, Schaefer F, Sporea I, Piscaglia F
  EFSUMB guidelines and recommendations on the clinical use of ultrasound elastography. Part 1: Basic principles and technology. Ultraschall Med. 2013 Apr;34(2):169-84. doi: 10.1055/s-0033-1335205. Epub 2013 Apr 4.
•   Bieri D, Reeve RA, Champion GD, Addicoat L, Ziegler JB
  The Faces Pain Scale for the self-assessment of the severity of pain experienced by children: development, initial validation, and preliminary investigation for ratio scale properties. Pain. 1990 May;41(2):139-50.
•   Cho Y, Tokuhara D, Morikawa H, Kuwae Y, Hayashi E, Hirose M, Hamazaki T, Tanaka A, Kawamura T, Kawada N, Shintaku H
  Transient Elastography-Based Liver Profiles in a Hospital-Based Pediatric Population in Japan. PLoS One. 2015 Sep 23;10(9):e0137239. doi: 10.1371/journal.pone.0137239. eCollection 2015.
•   Cosgrove D, Piscaglia F, Bamber J, Bojunga J, Correas JM, Gilja OH, Klauser AS, Sporea I, Calliada F, Cantisani V, D'Onofrio M, Drakonaki EE, Fink M, Friedrich-Rust M, Fromageau J, Havre RF, Jenssen C, Ohlinger R, Saftoiu A, Schaefer F, Dietrich CF; EFSUMB
  EFSUMB guidelines and recommendations on the clinical use of ultrasound elastography. Part 2: Clinical applications. Ultraschall Med. 2013 Jun;34(3):238-53. doi: 10.1055/s-0033-1335375. Epub 2013 Apr 19.
•   de Lédinghen V, Le Bail B, Rebouissoux L, Fournier C, Foucher J, Miette V, Castéra L, Sandrin L, Merrouche W, Lavrand F, Lamireau T
  Liver stiffness measurement in children using FibroScan: feasibility study and comparison with Fibrotest, aspartate transaminase to platelets ratio index, and liver biopsy. J Pediatr Gastroenterol Nutr. 2007 Oct;45(4):443-50.
•   de Lédinghen V, Vergniol J, Foucher J, El-Hajbi F, Merrouche W, Rigalleau V
  Feasibility of liver transient elastography with FibroScan using a new probe for obese patients. Liver Int. 2010 Aug;30(7):1043-8. doi: 10.1111/j.1478-3231.2010.02258.x. Epub 2010 May 14.
•   Engelmann G, Gebhardt C, Wenning D, Wühl E, Hoffmann GF, Selmi B, Grulich-Henn J, Schenk JP, Teufel U
  Feasibility study and control values of transient elastography in healthy children. Eur J Pediatr. 2012 Feb;171(2):353-60. doi: 10.1007/s00431-011-1558-7. Epub 2011 Aug 23.
•   Fitzpatrick E, Quaglia A, Vimalesvaran S, Basso MS, Dhawan A
  Transient elastography is a useful noninvasive tool for the evaluation of fibrosis in paediatric chronic liver disease. J Pediatr Gastroenterol Nutr. 2013 Jan;56(1):72-6. doi: 10.1097/MPG.0b013e31826f2760.
•   Friedrich-Rust M, Hadji-Hosseini H, Kriener S, Herrmann E, Sircar I, Kau A, Zeuzem S, Bojunga J
  Transient elastography with a new probe for obese patients for non-invasive staging of non-alcoholic steatohepatitis. Eur Radiol. 2010 Oct;20(10):2390-6. doi: 10.1007/s00330-010-1820-9. Epub 2010 Jun 6.
•   Friedrich-Rust M, Ong MF, Martens S, Sarrazin C, Bojunga J, Zeuzem S, Herrmann E
  Performance of transient elastography for the staging of liver fibrosis: a meta-analysis. Gastroenterology. 2008 Apr;134(4):960-74. doi: 10.1053/j.gastro.2008.01.034. Epub 2008 Jan 18. Review.
•   Fung J, Lee CK, Chan M, Seto WK, Wong DK, Lai CL, Yuen MF
  Defining normal liver stiffness range in a normal healthy Chinese population without liver disease. PLoS One. 2013 Dec 26;8(12):e85067. doi: 10.1371/journal.pone.0085067. eCollection 2013.
•   Goldschmidt I, Stieghorst H, Munteanu M, Poynard T, Schlue J, Streckenbach C, Baumann U
  The use of transient elastography and non-invasive serum markers of fibrosis in pediatric liver transplant recipients. Pediatr Transplant. 2013 Sep;17(6):525-34. doi: 10.1111/petr.12116. Epub 2013 Jun 27.
•   Goldschmidt I, Streckenbach C, Dingemann C, Pfister ED, di Nanni A, Zapf A, Baumann U
  Application and limitations of transient liver elastography in children. J Pediatr Gastroenterol Nutr. 2013 Jul;57(1):109-13. doi: 10.1097/MPG.0b013e31829206a0.
•   Kim S, Kang Y, Lee MJ, Kim MJ, Han SJ, Koh H
  Points to be considered when applying FibroScan S probe in children with biliary atresia. J Pediatr Gastroenterol Nutr. 2014 Nov;59(5):624-8. doi: 10.1097/MPG.0000000000000489.
•   Kim SY, Seok JY, Han SJ, Koh H
  Assessment of liver fibrosis and cirrhosis by aspartate aminotransferase-to-platelet ratio index in children with biliary atresia. J Pediatr Gastroenterol Nutr. 2010 Aug;51(2):198-202. doi: 10.1097/MPG.0b013e3181da1d98.
•   Lee CK, Mitchell PD, Raza R, Harney S, Wiggins SM, Jonas MM
  Validation of Transient Elastography Cut Points to Assess Advanced Liver Fibrosis in Children and Young Adults: The Boston Children's Hospital Experience. J Pediatr. 2018 Jul;198:84-89.e2. doi: 10.1016/j.jpeds.2018.02.062.
•   Lee CK, Perez-Atayde AR, Mitchell PD, Raza R, Afdhal NH, Jonas MM
  Serum biomarkers and transient elastography as predictors of advanced liver fibrosis in a United States cohort: the Boston children's hospital experience. J Pediatr. 2013 Oct;163(4):1058-64.e2. doi: 10.1016/j.jpeds.2013.04.044. Epub 2013 Jun 5.
•   Leung DH, Khan M, Minard CG, Guffey D, Ramm LE, Clouston AD, Miller G, Lewindon PJ, Shepherd RW, Ramm GA
  Aspartate aminotransferase to platelet ratio and fibrosis-4 as biomarkers in biopsy-validated pediatric cystic fibrosis liver disease. Hepatology. 2015 Nov;62(5):1576-83. doi: 10.1002/hep.28016. Epub 2015 Sep 28. Erratum in: Hepatology. 2017 Jan;65(1):397.
•   Mansoor S, Yerian L, Kohli R, Xanthakos S, Angulo P, Ling S, Lopez R, Christine CK, Feldstein AE, Alkhouri N
  The evaluation of hepatic fibrosis scores in children with nonalcoholic fatty liver disease. Dig Dis Sci. 2015 May;60(5):1440-7. doi: 10.1007/s10620-014-3494-7. Epub 2014 Dec 25.
•   McGoogan KE, Smith PB, Choi SS, Berman W, Jhaveri R
  Performance of the AST-to-platelet ratio index as a noninvasive marker of fibrosis in pediatric patients with chronic viral hepatitis. J Pediatr Gastroenterol Nutr. 2010 Mar;50(3):344-6. doi: 10.1097/MPG.0b013e3181aed725.
•   Menten R, Leonard A, Clapuyt P, Vincke P, Nicolae AC, Lebecque P
  Transient elastography in patients with cystic fibrosis. Pediatr Radiol. 2010 Jul;40(7):1231-5. doi: 10.1007/s00247-009-1531-z. Epub 2010 Feb 5.
•   Myers RP, Pomier-Layrargues G, Kirsch R, Pollett A, Duarte-Rojo A, Wong D, Beaton M, Levstik M, Crotty P, Elkashab M
  Feasibility and diagnostic performance of the FibroScan XL probe for liver stiffness measurement in overweight and obese patients. Hepatology. 2012 Jan;55(1):199-208. doi: 10.1002/hep.24624. Epub 2011 Nov 18.
•   Nobili V, Vizzutti F, Arena U, Abraldes JG, Marra F, Pietrobattista A, Fruhwirth R, Marcellini M, Pinzani M
  Accuracy and reproducibility of transient elastography for the diagnosis of fibrosis in pediatric nonalcoholic steatohepatitis. Hepatology. 2008 Aug;48(2):442-8. doi: 10.1002/hep.22376.
•   Roulot D, Czernichow S, Le Clésiau H, Costes JL, Vergnaud AC, Beaugrand M
  Liver stiffness values in apparently healthy subjects: influence of gender and metabolic syndrome. J Hepatol. 2008 Apr;48(4):606-13. doi: 10.1016/j.jhep.2007.11.020. Epub 2008 Jan 3.
•   Rubio A, Monpoux F, Huguon E, Truchi R, Triolo V, Rosenthal-Allieri MA, Deville A, Rosenthal E, Boutté P, Tran A
  Noninvasive procedures to evaluate liver involvement in HIV-1 vertically infected children. J Pediatr Gastroenterol Nutr. 2009 Nov;49(5):599-606. doi: 10.1097/MPG.0b013e3181a15b72.
•   Shen QL, Chen YJ, Wang ZM, Zhang TC, Pang WB, Shu J, Peng CH
  Assessment of liver fibrosis by Fibroscan as compared to liver biopsy in biliary atresia. World J Gastroenterol. 2015 Jun 14;21(22):6931-6. doi: 10.3748/wjg.v21.i22.6931.
•   Sterling RK, Lissen E, Clumeck N, Sola R, Correa MC, Montaner J, S Sulkowski M, Torriani FJ, Dieterich DT, Thomas DL, Messinger D, Nelson M; APRICOT Clinical Investigators
  Development of a simple noninvasive index to predict significant fibrosis in patients with HIV/HCV coinfection. Hepatology. 2006 Jun;43(6):1317-25.
•   Tokuhara D, Cho Y, Shintaku H
  Transient Elastography-Based Liver Stiffness Age-Dependently Increases in Children. PLoS One. 2016 Nov 18;11(11):e0166683. doi: 10.1371/journal.pone.0166683. eCollection 2016.
•   Vinciguerra T, Brunati A, David E, Longo F, Pinon M, Ricceri F, Castellino L, Piga A, Giraudo MT, Tandoi F, Cisarò F, Dell Olio D, Isolato G, Romagnoli R, Salizzoni M, Calvo PL
  Transient elastography for non-invasive evaluation of post-transplant liver graft fibrosis in children. Pediatr Transplant. 2018 Mar;22(2). doi: 10.1111/petr.13125. Epub 2018 Jan 25.
•   Wai CT, Greenson JK, Fontana RJ, Kalbfleisch JD, Marrero JA, Conjeevaram HS, Lok AS
  A simple noninvasive index can predict both significant fibrosis and cirrhosis in patients with chronic hepatitis C. Hepatology. 2003 Aug;38(2):518-26.
•   Yang HR, Kim HR, Kim MJ, Ko JS, Seo JK
  Noninvasive parameters and hepatic fibrosis scores in children with nonalcoholic fatty liver disease. World J Gastroenterol. 2012 Apr 7;18(13):1525-30. doi: 10.3748/wjg.v18.i13.1525.

Special Considerations for the Use of the Transient Elastography Paediatric Probe, Compared to the Standard M Probe, Indirect Serological Markers and Histology

Details for clinical trial NCT04380493