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Clinical Trials/NCT04380493
NCT04380493CompletedNot Applicable

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

Hospital Vall d'Hebron1 site in 1 country141 target enrollmentStarted: May 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
141
Locations
1
Primary Endpoint
Validation of FibroScan's® pediatric (S) probe in children

Study Overview

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

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
— to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Validation of indirect fibrosis markers(4 years)

Investigators

Sponsor
Hospital Vall d'Hebron
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jesús Quintero

Pediatric Hepatologist, physician

Hospital Vall d'Hebron

Study Sites (1)

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