ElastographyNCT04380493
The Use of the Transient Elastography Paediatric Probe, Compared to the M Probe, Indirect Biomarkers and Histology
An observational study of Elastography and Fibrosis, Liver, run by Hospital Vall d'Hebron at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Elastography, Fibrosis, Liver, Pediatrics
- What is being tested?
- hepatic transient elastography using S probe and M probe
- How many people
- 141 participants
- Where
- 1 siteSpain
- Study dates
- May 2015to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients of both sexes, aged 0 months to 18 years, suffering from various chronic liver diseases.
Who may be able to join
- 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.
Who cannot join
- Patients who do not meet all the inclusion criteria for inclusion in the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Special Considerations for the Use of the Transient Elastography Paediatric Probe, Compared to the Standard M Probe, Indirect Serological Markers and Histology
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
Read the detailed description
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.
Liver 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%.
The 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:
- Fibrosis 4 Score (FIB-4) = Age (years) x AST (U/L) / platelets (109/L) x √ALT (U/L).
- AST to Platelet Radio Index (APRI) = AST (upper normal limit) (UI/l)/ platelets x 109 x 100.
Eighteen 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.
The 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.).
- Conditions
- Elastography, Fibrosis, Liver, Pediatrics, Chronic Liver Disease
- Being tested
- hepatic transient elastography using S probe and M probe
- Keywords
- Elastography, liver biopsy, biopsy, indirect biomarkers
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatic transient elastography using S probe and M probeDiagnostic test
Also called Compare results with liver biopsy, Calculate indirect fibrosis markers (APRI and FIB-4)
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 years
Secondary outcomes (1)
Validation of indirect fibrosis markers
To assess whether indirect fibrosis markers (APRI and FIB-4) are a valid tool to detect absence or mild fibrosis in paediatric patients
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study startMay 2015
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for ElastographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Vall d'Hebron
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesús Quintero, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380493
- Sponsor's protocol ID
- PR(AMI)147/2019
- Status last verified
- May 2020
- First submitted
- 5 May 2020
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18222014Friedrich-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.
PubMed 18395077Bamber 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.
PubMed 23558397Cosgrove 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.
PubMed 23605169Sterling 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.
PubMed 16729309Wai 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.
PubMed 12883497Bieri 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.
PubMed 2367140Fitzpatrick 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.
PubMed 22922372de 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.
PubMed 18030211Tokuhara 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.
PubMed 27861607Cho 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.
PubMed 26398109Menten 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.
PubMed 20135110Engelmann 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.
PubMed 21861093Goldschmidt 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.
PubMed 23539048Alkhouri 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.
PubMed 23146095
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Considerations for the Use of the Transient Elastography Paediatric Probe, Compared to the Standard M Probe, Indirect Serological Markers and Histology
- ClinicalTrials.gov ID
- NCT04380493
- Acronym / sponsor ID
- PR(AMI)147/2019
- Conditions
- Elastography, Fibrosis, Liver, Pediatrics, Chronic Liver Disease
- Keywords
- Elastography, liver biopsy, biopsy, indirect biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Hospital Vall d'HebronUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Liver 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%.
The 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:
- Fibrosis 4 Score (FIB-4) = Age (years) x AST (U/L) / platelets (109/L) x √ALT (U/L).
- AST to Platelet Radio Index (APRI) = AST (upper normal limit) (UI/l)/ platelets x 109 x 100.
Eighteen 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.
The 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.).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients of both sexes, aged 0 months to 18 years, suffering from various chronic liver diseases.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who do not meet all the inclusion criteria for inclusion in the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hepatic transient elastography using S probe and M probeAlso: Compare results with liver biopsy, Calculate indirect fibrosis markers (APRI and FIB-4) | Diagnostic test | – |
Primary outcome
Validation of FibroScan's® pediatric (S) probe in children
Time frame: 4 years
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
1 secondary outcome
Validation of indirect fibrosis markers
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Background: PubMed 18222014Roulot 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.
- Background: PubMed 18395077Friedrich-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.
- Background: PubMed 23558397Bamber 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.
- Background: PubMed 23605169Cosgrove 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.
- Background: PubMed 16729309Sterling 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.
- Background: PubMed 12883497Wai 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.
- Background: PubMed 2367140Bieri 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.
- Background: PubMed 22922372Fitzpatrick 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.
- Background: PubMed 18030211de 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.
- Background: PubMed 27861607Tokuhara 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.
- Background: PubMed 26398109Cho 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.
- Background: PubMed 20135110Menten 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elastography and Fibrosis, Liver, run by Hospital Vall d'Hebron at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of FibroScan's® pediatric (S) probe in children (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04380493, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2020.