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RecruitingNCT04619966Updated Feb 29, 2024

Ultrasound Measurements of Hepatic Vasculatures and Hepatic Doppler Assessment of Healthy Children

An observational study in Portal Vein, Hepatic Veins and Hepatic Artery, sponsored by Hong Kong Children's Hospital. Recruiting at 1 site in Hong Kong. Open to participants aged 1 Day to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-29.

Sponsored by Hong Kong Children's Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started Nov 2020; still recruiting 6 years later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
300
Ages
1 Day to 18 Years
Sex
All
01

Study summary

Flow dynamics in the liver is altered in different hepatobiliary and cardiac pathologies, causing changes in hepatic vasculatures sizes and flow pattern changes which can be assessed by ultrasound (USG) study. Before one can use these measurements and observations to diagnose pathologies, a clear grasp of normality is crucial.

In the field of pediatrics, this is particularly challenging as the normal range of measurements may change with age, weight, height, gender and race of children.

Taking hepatic veno-occlusive disease as an example, current literature is conflicting regarding whether sonographic findings show consistent association with the disease. Sonographic findings therefore now have limited role in contributing to the diagnosis.

This may be related to the lack of a robust age corrected normal range of measurement for reference.

Existing literature shows that the normal portal vein diameter varies with age, weight and height and possibly gender. Literature for normal measurements of hepatic vein and hepatic artery in children is lacking.

In this study, the investigators aim to conduct a prospective, cross-section observational study to establish the normal measurements ranges of hepatic vein, hepatic artery and portal vein in healthy children in the investigators' locality.

Flow patterns, including qualitative assessment and quantitative measurements of resistive index and flow velocities will also be assessed.

These age corrected normal measurements will be very helpful in the diagnosis and follow-up of hepatobiliary and cardiac pathologies associated with alterations in dynamics of hepatic circulation.

Read the detailed description

Trial Objectives and Purpose:

  1. To establish normal limits of diameter of hepatic vein, hepatic artery and portal vein according to age, weight, height and gender.
  2. To establish normal waveform pattern in ultrasound Doppler assessment of hepatic vein, hepatic artery and portal vein. (Qualitative analysis)
  3. To establish normal limits of flow parameters assessed by ultrasound Doppler in hepatic vein, hepatic artery and portal vein according to age, weight, height and gender.

Trial Design:

A prospective cross-section observational study.

Recruitment of study subjects:

Patients attending Hong Kong Children's Hospital for clinically indicated USG examination will be invited to participate in this study under specific inclusion and exclusion criteria.

Treatment of subjects:

Recruited subjects will proceed to the clinically indicated USG study they are referred for first. After the clinically indicated USG study is completed, additional USG \& Doppler assessment of hepatic vasculatures will be performed, taking an additional 5 - 10 minutes.

All examinations will be done using a Philips EPIQ 5G ultrasound machine. Curvilinear or linear probe will be used depending on subjects' physique. Size measurements, qualitative and quantitative Doppler assessment of hepatic vein, hepatic artery and portal vein will be made and recorded.

Statistical method to be employed:

Continuous variables will be tested for normality by Shapiro-Wilk's test. Simple statistics including mean and standard deviations (+/- 2 SD) will be used to determine normal ranges for age.

Comparisons will be done by student's t-test. Relations between height, weight and gender with vessels diameter will be tested by Pearson correlation.

Linear multiple regression analysis will be utilized with vessels diameter as the dependent variable.

Number of subject to be enrolled (observation study): 300

Rationale:

Sample size = (Standard normal variate)2 X (Standard deviation)2 / Presicion2 Sample size = 1.962 X 22 / 12 Sample size = 15.37

Standard normal variate = 1.96 at 5% Type I error Standard deviation = up to 2mm (from prior study of portal vein diameter) Precision = 1mm

In view of aim of determining age corrected normal range of vessels diameter in children, a much bigger sample size will be obtained to improve accuracy.

Target to include 300 children in this study.

Age groups:

Around 30 cases for each of the following age groups:

  1. 0 - 1 years old
  2. 1 - 2 years old
  3. 2 - 4 years old
  4. 4 - 6 years old
  5. 6 - 8 years old
  6. 8 - 10 years old
  7. 10 - 12 years old
  8. 12 - 14 years old
  9. 14 - 16 years old
  10. 16- 18 years old
02

Conditions studied

  • Portal Vein
  • Hepatic Veins
  • Hepatic Artery
  • Liver Circulation
03

In context

Lead sponsor

Hong Kong Children's Hospital is the lead sponsor of 13 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients attending Hong Kong Children's Hospital for clinically indicated USG examination will be invited to participate in this study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient \< / = 18 years of age.
  2. No history of hepatobiliary nor cardiac pathology as checked with record in ePR. Verbal confirmation will be done with patient or parent / legal guardian.
  3. Attending USG study other than that of the hepatobiliary system. (ie. Patients attending for thyroid USG, urinary system USG, musculoskeletal system USG etc.)

Exclusion criteria

Exclusion Criteria:

  1. Patient > 18 years of age
  2. Known history of hepatobiliary or cardiac pathology.
  3. Unstable patients.
  4. Intolerance of USG examination
  5. Uncooperative patients.
  6. Patient requiring sedation for USG study.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Hepatic veins diameter (in mm) measured by grey scale ultrasound at 1 - 2 cm from confluence with inferior vena cava

    Right, middle and left hepatic vein diameter (in mm) measured by grey scale Ultrasound at location 1 - 2 cm from confluence with inferior vena cava, measured in longitudinal axis

    Time frame: Baseline

  2. Hepatic veins Doppler assessment of flow direction (towards or away from inferior vena cava)

    Ultrasound Doppler assessment of right, middle and left hepatic veins for flow direction (towards or away from inferior vena cava)

    Time frame: Baseline

  3. Hepatic veins Doppler assessment of flow pulsatility (yes or no)

    Ultrasound Doppler assessment of right, middle and left hepatic veins for flow pulsatility (yes or no)

    Time frame: Baseline

  4. Hepatic veins Doppler assessment of flow phasicity (monophasic, biphasic or triphasic)

    Ultrasound Doppler assessment of right, middle and left hepatic veins for flow phasicity (monophasic, biphasic or triphasic)

    Time frame: Baseline

  5. Hepatic veins Quantitative Doppler measurement of maximum flow rate (cm/s)

    Ultrasound Doppler quantitative measurement of right, middle and left hepatic veins maximum flow rate (cm/s)

    Time frame: Baseline

  6. Hepatic veins Quantitative Doppler measurement of minimum flow rate (cm/s)

    Ultrasound Doppler quantitative measurement of right, middle and left hepatic veins minimum flow rate (cm/s)

    Time frame: Baseline

  7. Hepatic veins Quantitative Doppler measurement of pulsatility index (only if pulsatility is present)

    Ultrasound Doppler quantitative measurement of right, middle and left hepatic veins pulsatility index (Only if pulsatility is present)

    Time frame: Baseline

  8. Hepatic artery diameter (in mm) measured by grey scale ultrasound at liver hilum

    Hepatic artery diameter (in mm) measured by grey scale ultrasound at the hepatic hilum (longitudinal axis)

    Time frame: Baseline

  9. Hepatic artery Doppler assessment of flow direction (hepatofugal or hepatopetal)

    Ultrasound Doppler assessment of hepatic artery flow direction (hepatofugal or hepatopetal)

    Time frame: Baseline

  10. Hepatic artery Doppler assessment of flow pulsatility (yes or no)

    Ultrasound Doppler assessment of hepatic artery flow pulsatility (yes or no)

    Time frame: Baseline

  11. Hepatic artery Doppler assessment of flow phasicity (monophasic, biphasic or triphasic)

    Ultrasound Doppler assessment of hepatic artery flow phasicity (monophasic, biphasic or triphasic)

    Time frame: Baseline

  12. Hepatic artery quantitative Doppler measurement of peak systolic velocity (cm/s)

    Ultrasound Doppler quantitative measurement of hepatic artery peak systolic velocity (cm/s)

    Time frame: Baseline

  13. Hepatic artery quantitative Doppler measurement of end diastolic velocity (cm/s)

    Ultrasound Doppler quantitative measurement of hepatic artery end diastolic velocity (cm/s)

    Time frame: Baseline

  14. Hepatic artery quantitative Doppler measurement of pulsatility index

    Ultrasound Doppler quantitative measurement of hepatic artery pulsatility index

    Time frame: Baseline

  15. Hepatic artery quantitative Doppler measurement of resistive index

    Ultrasound Doppler quantitative measurement of hepatic artery resistive index

    Time frame: Baseline

  16. Hepatic artery quantitative Doppler measurement of flow volume (ml/s) (measured if feasible)

    Ultrasound Doppler quantitative measurement of hepatic artery flow volume (ml/s)

    Time frame: Baseline

  17. Portal vein diameter (in mm) measured by grey scale ultrasound at liver hilum

    Portal vein diameter (in mm) measured by grey scale ultrasound at liver hilum (longitudinal axis)

    Time frame: Baseline

  18. Portal vein Doppler assessment of flow direction (hepatopetal or hepatofugal)

    Ultrasound Doppler assessment of portal vein flow direction (hepatopetal or hepatofugal)

    Time frame: Baseline

  19. Portal vein Doppler assessment of flow pulsatility (yes or no)

    Ultrasound Doppler assessment of portal vein pulsatility (yes or no)

    Time frame: Baseline

  20. Portal vein Doppler assessment of flow phasicity (monophasic, biphasic or triphasic)

    Ultrasound Doppler assessment of portal vein flow phasicity (monophasic, biphasic or triphasic)

    Time frame: Baseline

  21. Portal vein quantitative Doppler measurement of maximum flow rate (cm/s)

    Ultrasound Doppler quantitative measurement of portal vein maximum flow rate (cm/s)

    Time frame: Baseline

  22. Portal vein quantitative Doppler measurement of minimum flow rate (cm/s)

    Ultrasound Doppler measurement of portal vein minimum flow rate (cm/s)

    Time frame: Baseline

  23. Portal vein quantitative Doppler measurement of pulsatility index (only if pulsatility is present)

    Ultrasound Doppler quantitative measurement of portal vein pulsatility index

    Time frame: Baseline

  24. Portal vein quantitative Doppler measurement of flow volume (ml/s)

    Ultrasound Doppler measurement of portal vein flow volume (ml/s)

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Patriquin HB, Perreault G, Grignon A, Boisvert J, Filiatrault D, Garel L, Blanchard H. Normal portal venous diameter in children. Pediatr Radiol. 1990;20(6):451-3. doi: 10.1007/BF02075206. PubMed 2392362 ↗
  • Soyupak S, Gunesli A, Seydaoglu G, Binokay F, Celiktas M, Inal M. Portal venous diameter in children: normal limits according to age, weight and height. Eur J Radiol. 2010 Aug;75(2):245-7. doi: 10.1016/j.ejrad.2009.03.052. Epub 2009 May 5. PubMed 19409745 ↗
  • Weinreb J, Kumari S, Phillips G, Pochaczevsky R. Portal vein measurements by real-time sonography. AJR Am J Roentgenol. 1982 Sep;139(3):497-9. doi: 10.2214/ajr.139.3.497. No abstract available. PubMed 6981312 ↗
  • Jequier S, Jequier JC, Hanquinet S, Gong J, Le Coultre C, Belli DC. Doppler waveform of hepatic veins in healthy children. AJR Am J Roentgenol. 2000 Jul;175(1):85-90. doi: 10.2214/ajr.175.1.1750085. PubMed 10882252 ↗
  • Herbetko J, Grigg AP, Buckley AR, Phillips GL. Venoocclusive liver disease after bone marrow transplantation: findings at duplex sonography. AJR Am J Roentgenol. 1992 May;158(5):1001-5. doi: 10.2214/ajr.158.5.1566656. PubMed 1566656 ↗
  • McCarville MB, Hoffer FA, Howard SC, Goloubeva O, Kauffman WM. Hepatic veno-occlusive disease in children undergoing bone-marrow transplantation: usefulness of sonographic findings. Pediatr Radiol. 2001 Feb;31(2):102-5. doi: 10.1007/s002470000373. PubMed 11214676 ↗
  • Hommeyer SC, Teefey SA, Jacobson AF, Higano CS, Bianco JA, Colacurcio CJ, McDonald GB. Venocclusive disease of the liver: prospective study of US evaluation. Radiology. 1992 Sep;184(3):683-6. doi: 10.1148/radiology.184.3.1509050. PubMed 1509050 ↗
  • Corbacioglu S, Carreras E, Ansari M, Balduzzi A, Cesaro S, Dalle JH, Dignan F, Gibson B, Guengoer T, Gruhn B, Lankester A, Locatelli F, Pagliuca A, Peters C, Richardson PG, Schulz AS, Sedlacek P, Stein J, Sykora KW, Toporski J, Trigoso E, Vetteranta K, Wachowiak J, Wallhult E, Wynn R, Yaniv I, Yesilipek A, Mohty M, Bader P. Diagnosis and severity criteria for sinusoidal obstruction syndrome/veno-occlusive disease in pediatric patients: a new classification from the European society for blood and marrow transplantation. Bone Marrow Transplant. 2018 Feb;53(2):138-145. doi: 10.1038/bmt.2017.161. Epub 2017 Jul 31. PubMed 28759025 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04619966
Lead sponsor
Hong Kong Children's Hospital
Responsible party
Pui Kwan Joyce Chan (Associate consultant radiologist, Deputy Head of Ultrasound team of radiology, Principle investigator, Hong Kong Children's Hospital) — Principal investigator
First posted
Nov 6, 2020
Start date
Nov 1, 2020
Primary completion
Jul 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Feb 29, 2024

Study contacts

Pui Kwan Joyce Chan, MBChB
Contact
cpk706@ha.org.hk
+85296362929
Pui Kwan Joyce Chan, MBChB
principal investigator · Hong Kong Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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