Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-31 @ 7:30 PM
Study NCT ID:
NCT04380493
Status:
COMPLETED
Last Update Posted:
2020-05-11
First Post:
2020-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of the Transient Elastography Paediatric Probe, Compared to the M Probe, Indirect Biomarkers and Histology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-07', 'studyFirstSubmitDate': '2020-05-05', 'studyFirstSubmitQcDate': '2020-05-05', 'lastUpdatePostDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Validation of FibroScan's® pediatric (S) probe in children", 'timeFrame': '4 years', 'description': "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"}], 'secondaryOutcomes': [{'measure': 'Validation of indirect fibrosis markers', 'timeFrame': '4 years', 'description': 'To assess whether indirect fibrosis markers (APRI and FIB-4) are a valid tool to detect absence or mild fibrosis in paediatric patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elastography', 'liver biopsy', 'biopsy', 'indirect biomarkers'], 'conditions': ['Elastography', 'Fibrosis, Liver', 'Pediatrics', 'Chronic Liver Disease']}, 'referencesModule': {'references': [{'pmid': '18222014', 'type': 'BACKGROUND', 'citation': 'Roulot D, Czernichow S, Le Clesiau H, Costes JL, Vergnaud AC, Beaugrand M. 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Ultraschall Med. 2013 Apr;34(2):169-84. doi: 10.1055/s-0033-1335205. Epub 2013 Apr 4."}, {'pmid': '23605169', 'type': 'BACKGROUND', 'citation': "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': '16729309', 'type': 'BACKGROUND', 'citation': '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. 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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': '23146095', 'type': 'BACKGROUND', 'citation': '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': '23759423', 'type': 'BACKGROUND', 'citation': "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': '24386446', 'type': 'BACKGROUND', 'citation': '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': '18563842', 'type': 'BACKGROUND', 'citation': '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': '19668009', 'type': 'BACKGROUND', 'citation': '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. 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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': '26078570', 'type': 'BACKGROUND', 'citation': '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': '23802661', 'type': 'BACKGROUND', 'citation': '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': '21898479', 'type': 'BACKGROUND', 'citation': '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': '20492500', 'type': 'BACKGROUND', 'citation': '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': '20526777', 'type': 'BACKGROUND', 'citation': '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': '20531020', 'type': 'BACKGROUND', 'citation': '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': '20118806', 'type': 'BACKGROUND', 'citation': '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': '26223427', 'type': 'BACKGROUND', 'citation': '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': '22509085', 'type': 'BACKGROUND', 'citation': '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': '25540086', 'type': 'BACKGROUND', 'citation': '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': '26925609', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': "A retrospective cohort study, including all patients younger than 18 years of age with chronic liver disease who underwent a transient elastography, was performed. The study was carried out in the joint Unit of Paediatric Complex Hepatology and Liver Transplant, encompassing two third level paediatric hospitals, between 2015 and 2019. The study protocol was approved by local ethic committee (identifier code: PR(AMI)147/2019) and informed consent was signed by patient's legal guardians and patients over 16 years old.\n\nLiver stiffness was assessed with FibroScan® (Echosens, France, model 502, class IIa, year 2010), which was performed by an experienced operator to avoid interobserver bias and in the same standardized conditions (fasting, decubitus position, right arm in maximal abduction, transducer placed over the right lobe). S probe (model 8; 5 MHz; diameter 5 mm), that measures depths ranging from 15-50 mm (S1: 15-40 mm; S2: 20-50 mm), was selected if chest circumference (CC) \\< 75 cm (S1: ≤ 45 cm; S2: 45-75 cm). M probe (3.5 MHz; diameter 7 mm), measuring depths range 35-75mm, was used if CC ≥ 75 cm. Both probes met the calibration terms. Elastographic parameters studied were: stiffness (KPa), interquartile range (IQR) and success rate (SR). Adult-validated liver stiffness measurement ranges to classify the fibrosis degree were taken as a reference: F0-F1 (≤7.6 KPa), F2 (7.7-9.4 KPa), F3 (9.5-14 KPa) and F4 (\\>14 KPa). The examination was successful when the median of at least 10 valid values, had a SR higher than 60% and with an IQR/LSM lower than 30%.\n\nThe following sociodemographic, clinical and analytical data were collected: age, sex, underlying liver disease and analytical parameters (alanine aminotransferase (ALT) U/L, aspartate aminotransferase (AST) U/L, gamma glutamyl transferase (GGT) U/L, total bilirubin (mg/dl), cholesterol (mg/dl), platelets (109/L), prothrombin time (%)). The following liver fibrosis test Scores were calculated using the obtained data:\n\n* Fibrosis 4 Score (FIB-4) = Age (years) x AST (U/L) / platelets (109/L) x √ALT (U/L).\n* AST to Platelet Radio Index (APRI) = AST (upper normal limit) (UI/l)/ platelets x 109 x 100.\n\nEighteen clinically indicated liver biopsies were performed and staged according METAVIR score (F0-F4). Blood test, fibrosis scores and biopsies were performed within 6 months of transient elastography. No clinical or analytical changes were observed during this period.\n\nThe Faces Pain Scale was used for assessing pain severity. Statistical analysis: Kolmogorov-Smirnov test checked out if variables followed a normal distribution. Continuous variables are presented as mean ± standard deviation or median (interquartile range) and categorical variables as number of subjects and percentage. Correlation between continuous variables were calculated using Pearson's and Spearman's correlation coefficient. The variance's analysis (ANOVA) and the Kruskal Wallis test were used to compare qualitative with quantitative variables. Two-tailed p-Values of \\<0.05 were considered as statistically significant. Sensitivity, specificity, positive predictive value and negative predictive value were calculated in the assessment of FIB-4 and APRI as a diagnostic test to detect absence or mild fibrosis (F0-F1), using the results obtained by TE as a reference. The statistical analyses were performed with SPSS software (v. 21, SPSS Inc., Chicago, IL, USA) and Prism (v. 7.04 GraphPad Software Inc.)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients of both sexes, aged 0 months to 18 years, suffering from various chronic liver diseases.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients younger than 18 years of age with chronic liver disease who underwent a transient elastography.\n* Parents / legal guardians and the patients themselves, if applicable, have read, understood and signed the informed consent of the study.\n\nExclusion Criteria:\n\n* Patients who do not meet all the inclusion criteria for inclusion in the study protocol.'}, 'identificationModule': {'nctId': 'NCT04380493', 'briefTitle': 'The Use of the Transient Elastography Paediatric Probe, Compared to the M Probe, Indirect Biomarkers and Histology', 'organization': {'class': 'OTHER', 'fullName': "Hospital Vall d'Hebron"}, 'officialTitle': 'Special Considerations for the Use of the Transient Elastography Paediatric Probe, Compared to the Standard M Probe, Indirect Serological Markers and Histology', 'orgStudyIdInfo': {'id': 'PR(AMI)147/2019'}}, 'armsInterventionsModule': {'interventions': [{'name': 'hepatic transient elastography using S probe and M probe', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Compare results with liver biopsy', 'Calculate indirect fibrosis markers (APRI and FIB-4)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Vall d'Hebron", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatric Hepatologist, physician', 'investigatorFullName': 'Jesús Quintero', 'investigatorAffiliation': "Hospital Vall d'Hebron"}}}}