Portal VeinNCT04619966
Ultrasound Measurements of Hepatic Vasculatures and Hepatic Doppler Assessment of Healthy Children
An observational study of Portal Vein and Hepatic Veins, run by Hong Kong Children's Hospital at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Portal Vein, Hepatic Veins, Hepatic Artery
- How many people
- 300 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2020to 31 Dec 2024
- 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 1 day to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients attending Hong Kong Children's Hospital for clinically indicated USG examination will be invited to participate in this study.
Who may be able to join
- 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.)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Children's Hospital
Hong Kong
Joyce Pui Kwan Chan, MBChB, +85296362929, cpk706@ha.org.hk
About this study
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.
Read more
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:
- To establish normal limits of diameter of hepatic vein, hepatic artery and portal vein according to age, weight, height and gender.
- To establish normal waveform pattern in ultrasound Doppler assessment of hepatic vein, hepatic artery and portal vein. (Qualitative analysis)
- 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:
- 0 - 1 years old
- 1 - 2 years old
- 2 - 4 years old
- 4 - 6 years old
- 6 - 8 years old
- 8 - 10 years old
- 10 - 12 years old
- 12 - 14 years old
- 14 - 16 years old
- 16- 18 years old
- Conditions
- Portal Vein, Hepatic Veins, Hepatic Artery, Liver Circulation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline
Hepatic artery Doppler assessment of flow direction (hepatofugal or hepatopetal)
Ultrasound Doppler assessment of hepatic artery flow direction (hepatofugal or hepatopetal)
Measured: Baseline
Hepatic artery Doppler assessment of flow pulsatility (yes or no)
Ultrasound Doppler assessment of hepatic artery flow pulsatility (yes or no)
Measured: Baseline
Hepatic artery Doppler assessment of flow phasicity (monophasic, biphasic or triphasic)
Ultrasound Doppler assessment of hepatic artery flow phasicity (monophasic, biphasic or triphasic)
Measured: Baseline
Hepatic artery quantitative Doppler measurement of peak systolic velocity (cm/s)
Ultrasound Doppler quantitative measurement of hepatic artery peak systolic velocity (cm/s)
Measured: Baseline
Hepatic artery quantitative Doppler measurement of end diastolic velocity (cm/s)
Ultrasound Doppler quantitative measurement of hepatic artery end diastolic velocity (cm/s)
Measured: Baseline
Hepatic artery quantitative Doppler measurement of pulsatility index
Ultrasound Doppler quantitative measurement of hepatic artery pulsatility index
Measured: Baseline
Hepatic artery quantitative Doppler measurement of resistive index
Ultrasound Doppler quantitative measurement of hepatic artery resistive index
Measured: 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)
Measured: 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)
Measured: Baseline
Portal vein Doppler assessment of flow direction (hepatopetal or hepatofugal)
Ultrasound Doppler assessment of portal vein flow direction (hepatopetal or hepatofugal)
Measured: Baseline
Portal vein Doppler assessment of flow pulsatility (yes or no)
Ultrasound Doppler assessment of portal vein pulsatility (yes or no)
Measured: Baseline
Portal vein Doppler assessment of flow phasicity (monophasic, biphasic or triphasic)
Ultrasound Doppler assessment of portal vein flow phasicity (monophasic, biphasic or triphasic)
Measured: Baseline
Portal vein quantitative Doppler measurement of maximum flow rate (cm/s)
Ultrasound Doppler quantitative measurement of portal vein maximum flow rate (cm/s)
Measured: Baseline
Portal vein quantitative Doppler measurement of minimum flow rate (cm/s)
Ultrasound Doppler measurement of portal vein minimum flow rate (cm/s)
Measured: Baseline
Portal vein quantitative Doppler measurement of pulsatility index (only if pulsatility is present)
Ultrasound Doppler quantitative measurement of portal vein pulsatility index
Measured: Baseline
Portal vein quantitative Doppler measurement of flow volume (ml/s)
Ultrasound Doppler measurement of portal vein flow volume (ml/s)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Nov 2020
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Portal VeinStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pui Kwan Joyce Chan, Hong Kong Children's Hospital
- Investigators
- Pui Kwan Joyce Chan, MBChB, Principal investigator, Hong Kong Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619966
- Sponsor's protocol ID
- HKCHUSG01
- Status last verified
- Feb 2024
- First submitted
- 29 Oct 2020
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 2392362Soyupak 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 19409745Weinreb 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 6981312Jequier 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 10882252Herbetko 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 1566656McCarville 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 11214676Hommeyer 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 1509050Corbacioglu 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Measurements of Hepatic Vasculatures and Hepatic Doppler Assessment of Healthy Children
- ClinicalTrials.gov ID
- NCT04619966
- Acronym / sponsor ID
- HKCHUSG01
- Conditions
- Portal Vein, Hepatic Veins, Hepatic Artery, Liver Circulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hong Kong Children's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Nov 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.
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.
Detailed description
Trial Objectives and Purpose:
- To establish normal limits of diameter of hepatic vein, hepatic artery and portal vein according to age, weight, height and gender.
- To establish normal waveform pattern in ultrasound Doppler assessment of hepatic vein, hepatic artery and portal vein. (Qualitative analysis)
- 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:
- 0 - 1 years old
- 1 - 2 years old
- 2 - 4 years old
- 4 - 6 years old
- 6 - 8 years old
- 8 - 10 years old
- 10 - 12 years old
- 12 - 14 years old
- 14 - 16 years old
- 16- 18 years old
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients attending Hong Kong Children's Hospital for clinically indicated USG examination will be invited to participate in this study.
Key inclusion criteria (3 listed)
- 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.)
Key exclusion criteria (6 listed)
- Patient > 18 years of age
- Known history of hepatobiliary or cardiac pathology.
- Unstable patients.
- Intolerance of USG examination
- Uncooperative patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hepatic veins diameter (in mm) measured by grey scale ultrasound at 1 - 2 cm from confluence with inferior vena cava
Time frame: Baseline
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
Hepatic veins Doppler assessment of flow direction (towards or away from inferior vena cava)
Time frame: Baseline
Ultrasound Doppler assessment of right, middle and left hepatic veins for flow direction (towards or away from inferior vena cava)
Hepatic veins Doppler assessment of flow pulsatility (yes or no)
Time frame: Baseline
Ultrasound Doppler assessment of right, middle and left hepatic veins for flow pulsatility (yes or no)
Hepatic veins Doppler assessment of flow phasicity (monophasic, biphasic or triphasic)
Time frame: Baseline
Ultrasound Doppler assessment of right, middle and left hepatic veins for flow phasicity (monophasic, biphasic or triphasic)
Hepatic veins Quantitative Doppler measurement of maximum flow rate (cm/s)
Time frame: Baseline
Ultrasound Doppler quantitative measurement of right, middle and left hepatic veins maximum flow rate (cm/s)
Hepatic veins Quantitative Doppler measurement of minimum flow rate (cm/s)
Time frame: Baseline
Ultrasound Doppler quantitative measurement of right, middle and left hepatic veins minimum flow rate (cm/s)
Hepatic veins Quantitative Doppler measurement of pulsatility index (only if pulsatility is present)
Time frame: Baseline
Ultrasound Doppler quantitative measurement of right, middle and left hepatic veins pulsatility index (Only if pulsatility is present)
Hepatic artery diameter (in mm) measured by grey scale ultrasound at liver hilum
Time frame: Baseline
Hepatic artery diameter (in mm) measured by grey scale ultrasound at the hepatic hilum (longitudinal axis)
Hepatic artery Doppler assessment of flow direction (hepatofugal or hepatopetal)
Time frame: Baseline
Ultrasound Doppler assessment of hepatic artery flow direction (hepatofugal or hepatopetal)
Hepatic artery Doppler assessment of flow pulsatility (yes or no)
Time frame: Baseline
Ultrasound Doppler assessment of hepatic artery flow pulsatility (yes or no)
Hepatic artery Doppler assessment of flow phasicity (monophasic, biphasic or triphasic)
Time frame: Baseline
Ultrasound Doppler assessment of hepatic artery flow phasicity (monophasic, biphasic or triphasic)
Hepatic artery quantitative Doppler measurement of peak systolic velocity (cm/s)
Time frame: Baseline
Ultrasound Doppler quantitative measurement of hepatic artery peak systolic velocity (cm/s)
Hepatic artery quantitative Doppler measurement of end diastolic velocity (cm/s)
Time frame: Baseline
Ultrasound Doppler quantitative measurement of hepatic artery end diastolic velocity (cm/s)
Hepatic artery quantitative Doppler measurement of pulsatility index
Time frame: Baseline
Ultrasound Doppler quantitative measurement of hepatic artery pulsatility index
Hepatic artery quantitative Doppler measurement of resistive index
Time frame: Baseline
Ultrasound Doppler quantitative measurement of hepatic artery resistive index
Hepatic artery quantitative Doppler measurement of flow volume (ml/s) (measured if feasible)
Time frame: Baseline
Ultrasound Doppler quantitative measurement of hepatic artery flow volume (ml/s)
Portal vein diameter (in mm) measured by grey scale ultrasound at liver hilum
Time frame: Baseline
Portal vein diameter (in mm) measured by grey scale ultrasound at liver hilum (longitudinal axis)
Portal vein Doppler assessment of flow direction (hepatopetal or hepatofugal)
Time frame: Baseline
Ultrasound Doppler assessment of portal vein flow direction (hepatopetal or hepatofugal)
Portal vein Doppler assessment of flow pulsatility (yes or no)
Time frame: Baseline
Ultrasound Doppler assessment of portal vein pulsatility (yes or no)
Portal vein Doppler assessment of flow phasicity (monophasic, biphasic or triphasic)
Time frame: Baseline
Ultrasound Doppler assessment of portal vein flow phasicity (monophasic, biphasic or triphasic)
Portal vein quantitative Doppler measurement of maximum flow rate (cm/s)
Time frame: Baseline
Ultrasound Doppler quantitative measurement of portal vein maximum flow rate (cm/s)
Portal vein quantitative Doppler measurement of minimum flow rate (cm/s)
Time frame: Baseline
Ultrasound Doppler measurement of portal vein minimum flow rate (cm/s)
Portal vein quantitative Doppler measurement of pulsatility index (only if pulsatility is present)
Time frame: Baseline
Ultrasound Doppler quantitative measurement of portal vein pulsatility index
Portal vein quantitative Doppler measurement of flow volume (ml/s)
Time frame: Baseline
Ultrasound Doppler measurement of portal vein flow volume (ml/s)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Background: PubMed 2392362Patriquin 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.
- Background: PubMed 19409745Soyupak 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.
- Background: PubMed 6981312Weinreb 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.
- Background: PubMed 10882252Jequier 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.
- Background: PubMed 1566656Herbetko 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.
- Background: PubMed 11214676McCarville 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.
- Background: PubMed 1509050Hommeyer 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.
- Background: PubMed 28759025Corbacioglu 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.
- 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.
Pui Kwan Joyce Chan, MBChB principal investigator
Hong Kong Children's Hospital
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 Portal Vein and Hepatic Veins, run by Hong Kong Children's Hospital at 1 site in Hong Kong.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Feb 2024. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pui Kwan Joyce Chan, MBChB (+85296362929, cpk706@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic veins diameter (in mm) measured by grey scale ultrasound at 1 - 2 cm from confluence with inferior vena cava (time frame: Baseline). The study lists 24 primary outcomes in all. 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 NCT04619966, which also lists 8 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 29 Feb 2024.