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

NCT04380493 | Completed

• 1 other identifier: PR(AMI)147/2019
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the reliability, reproducibility and accuracy of the paediatric probe of transient elastography in detecting liver fibrosis in children, besides its limitations and side effects. At the same time, to assess whether indirect fibrosis markers are a valid tool to detect absence or mild fibrosis in paediatric patients

Conditions

Elastography; Fibrosis, Liver; Pediatrics; Chronic Liver Disease

Keywords

Elastography; liver biopsy; biopsy; indirect biomarkers

Outcome Measures

Primary Outcomes (1)

• Validation of FibroScan's® pediatric (S) probe in children

  To describe our experience with FibroScan's® pediatric (S) probe; its reliability, reproducibility, and accuracy in detecting fibrosis, as compared to M probe and histology, as well as its limitations and side effects

  4 years

Secondary Outcomes (1)

• Validation of indirect fibrosis markers

  4 years

Interventions

hepatic transient elastography using S probe and M probe DIAGNOSTIC_TEST

Also known as: Compare results with liver biopsy, Calculate indirect fibrosis markers (APRI and FIB-4)

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients of both sexes, aged 0 months to 18 years, suffering from various chronic liver diseases.

You may qualify if:

• Patients younger than 18 years of age with chronic liver disease who underwent a transient elastography.
• Parents / legal guardians and the patients themselves, if applicable, have read, understood and signed the informed consent of the study.

Sponsors & Collaborators

• Hospital Vall d'Hebron: lead

Study Sites (1)

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (33)

• Roulot D, Czernichow S, Le Clesiau 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.

  PMID: 18222014 BACKGROUND

• 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.

  PMID: 18395077 BACKGROUND

• 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.

  PMID: 23558397 BACKGROUND

• 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.

  PMID: 23605169 BACKGROUND

• 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. doi: 10.1002/hep.21178.

  PMID: 16729309 BACKGROUND

• 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. doi: 10.1053/jhep.2003.50346.

  PMID: 12883497 BACKGROUND

• Bieri D, Reeve RA, Champion DG, 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):139-150. doi: 10.1016/0304-3959(90)90018-9.

  PMID: 2367140 BACKGROUND

• 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.

  PMID: 22922372 BACKGROUND

• de Ledinghen V, Le Bail B, Rebouissoux L, Fournier C, Foucher J, Miette V, Castera 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. doi: 10.1097/MPG.0b013e31812e56ff.

  PMID: 18030211 BACKGROUND

• 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.

  PMID: 27861607 BACKGROUND

• 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.

  PMID: 26398109 BACKGROUND

• 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.

  PMID: 20135110 BACKGROUND

• Engelmann G, Gebhardt C, Wenning D, Wuhl 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.

  PMID: 21861093 BACKGROUND

• 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.

  PMID: 23539048 BACKGROUND

• 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.

  PMID: 23146095 BACKGROUND

• 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.

  PMID: 23759423 BACKGROUND

• 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.

  PMID: 24386446 BACKGROUND

• 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.

  PMID: 18563842 BACKGROUND

• Rubio A, Monpoux F, Huguon E, Truchi R, Triolo V, Rosenthal-Allieri MA, Deville A, Rosenthal E, Boutte 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.

  PMID: 19668009 BACKGROUND

• Vinciguerra T, Brunati A, David E, Longo F, Pinon M, Ricceri F, Castellino L, Piga A, Giraudo MT, Tandoi F, Cisaro 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.

  PMID: 29369488 BACKGROUND

• 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.

  PMID: 29685617 BACKGROUND

• 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.

  PMID: 25003372 BACKGROUND

• 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.

  PMID: 26078570 BACKGROUND

• 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.

  PMID: 23802661 BACKGROUND

• 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.

  PMID: 21898479 BACKGROUND

• de Ledinghen 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.

  PMID: 20492500 BACKGROUND

• 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.

  PMID: 20526777 BACKGROUND

• 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.

  PMID: 20531020 BACKGROUND

• 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.

  PMID: 20118806 BACKGROUND

• 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.

  PMID: 26223427 BACKGROUND

• 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.

  PMID: 22509085 BACKGROUND

• 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.

  PMID: 25540086 BACKGROUND

• 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.

  PMID: 26925609 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Hepatologist, physician

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 8, 2020
• Study Start: May 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)