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

May 7, 2020 updated by: Jesús Quintero, Hospital Vall d'Hebron

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

141

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients who do not meet all the inclusion criteria for inclusion in the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of indirect fibrosis markers
Time Frame: 4 years
To assess whether indirect fibrosis markers (APRI and FIB-4) are a valid tool to detect absence or mild fibrosis in paediatric patients
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Vall d'Hebron

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (Actual)

May 8, 2020

Study Record Updates

Last Update Posted (Actual)

May 11, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AMI)147/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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