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

NCT04619966 | Recruiting

• 1 other identifier: HKCHUSG01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Portal Vein; Hepatic Veins; Hepatic Artery; Liver Circulation

Outcome Measures

Primary Outcomes (24)

• 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

  Baseline

• 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)

  Baseline

• 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)

  Baseline

• 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)

  Baseline

• 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)

  Baseline

• 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)

  Baseline

• 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)

  Baseline

• 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)

  Baseline

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

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

  Baseline

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

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

  Baseline

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

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

  Baseline

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

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

  Baseline

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

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

  Baseline

• Hepatic artery quantitative Doppler measurement of pulsatility index

  Ultrasound Doppler quantitative measurement of hepatic artery pulsatility index

  Baseline

• Hepatic artery quantitative Doppler measurement of resistive index

  Ultrasound Doppler quantitative measurement of hepatic artery resistive index

  Baseline

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

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

  Baseline

• 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)

  Baseline

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

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

  Baseline

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

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

  Baseline

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

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

  Baseline

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

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

  Baseline

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

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

  Baseline

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

  Ultrasound Doppler quantitative measurement of portal vein pulsatility index

  Baseline

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

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

  Baseline

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Patient \> 18 years of age
• Known history of hepatobiliary or cardiac pathology.
• Unstable patients.
• Intolerance of USG examination
• Uncooperative patients.
• Patient requiring sedation for USG study.

Sponsors & Collaborators

• Hong Kong Children's Hospital: lead

Study Sites (1)

Hong Kong Children's Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (8)

• 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.

  PMID: 2392362 BACKGROUND

• 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.

  PMID: 19409745 BACKGROUND

• 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.

  PMID: 6981312 BACKGROUND

• 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.

  PMID: 10882252 BACKGROUND

• 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.

  PMID: 1566656 BACKGROUND

• 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.

  PMID: 11214676 BACKGROUND

• 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.

  PMID: 1509050 BACKGROUND

• 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.

  PMID: 28759025 BACKGROUND

Study Officials

• Pui Kwan Joyce Chan, MBChB

  Hong Kong Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pui Kwan Joyce Chan, MBChB

CONTACT

+85296362929; cpk706@ha.org.hk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate consultant radiologist, Deputy Head of Ultrasound team of radiology, Principle investigator

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 6, 2020
• Study Start: November 1, 2020
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)