Ultrasound Measurements of Hepatic Vasculatures and Hepatic Doppler Assessment of Healthy Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Hepatic veins diameter (in mm) measured by grey scale ultrasound at 1 - 2 cm from confluence with inferior vena cava
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.)
排除标准
- •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.
结局指标
主要结局
Hepatic veins diameter (in mm) measured by grey scale ultrasound at 1 - 2 cm from confluence with inferior vena cava
时间窗: 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 artery quantitative Doppler measurement of pulsatility index
时间窗: Baseline
Ultrasound Doppler quantitative measurement of hepatic artery pulsatility index
Hepatic veins Quantitative Doppler measurement of maximum flow rate (cm/s)
时间窗: Baseline
Ultrasound Doppler quantitative measurement of right, middle and left hepatic veins maximum flow rate (cm/s)
Hepatic artery Doppler assessment of flow pulsatility (yes or no)
时间窗: Baseline
Ultrasound Doppler assessment of hepatic artery flow pulsatility (yes or no)
Hepatic veins Doppler assessment of flow direction (towards or away from inferior vena cava)
时间窗: 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 phasicity (monophasic, biphasic or triphasic)
时间窗: Baseline
Ultrasound Doppler assessment of right, middle and left hepatic veins for flow phasicity (monophasic, biphasic or triphasic)
Hepatic veins Quantitative Doppler measurement of pulsatility index (only if pulsatility is present)
时间窗: 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
时间窗: Baseline
Hepatic artery diameter (in mm) measured by grey scale ultrasound at the hepatic hilum (longitudinal axis)
Hepatic veins Doppler assessment of flow pulsatility (yes or no)
时间窗: Baseline
Ultrasound Doppler assessment of right, middle and left hepatic veins for flow pulsatility (yes or no)
Hepatic veins Quantitative Doppler measurement of minimum flow rate (cm/s)
时间窗: Baseline
Ultrasound Doppler quantitative measurement of right, middle and left hepatic veins minimum flow rate (cm/s)
Hepatic artery Doppler assessment of flow direction (hepatofugal or hepatopetal)
时间窗: Baseline
Ultrasound Doppler assessment of hepatic artery flow direction (hepatofugal or hepatopetal)
Hepatic artery Doppler assessment of flow phasicity (monophasic, biphasic or triphasic)
时间窗: Baseline
Ultrasound Doppler assessment of hepatic artery flow phasicity (monophasic, biphasic or triphasic)
Hepatic artery quantitative Doppler measurement of peak systolic velocity (cm/s)
时间窗: Baseline
Ultrasound Doppler quantitative measurement of hepatic artery peak systolic velocity (cm/s)
Hepatic artery quantitative Doppler measurement of flow volume (ml/s) (measured if feasible)
时间窗: 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
时间窗: Baseline
Portal vein diameter (in mm) measured by grey scale ultrasound at liver hilum (longitudinal axis)
Hepatic artery quantitative Doppler measurement of end diastolic velocity (cm/s)
时间窗: Baseline
Ultrasound Doppler quantitative measurement of hepatic artery end diastolic velocity (cm/s)
Portal vein Doppler assessment of flow direction (hepatopetal or hepatofugal)
时间窗: Baseline
Ultrasound Doppler assessment of portal vein flow direction (hepatopetal or hepatofugal)
Portal vein Doppler assessment of flow pulsatility (yes or no)
时间窗: Baseline
Ultrasound Doppler assessment of portal vein pulsatility (yes or no)
Hepatic artery quantitative Doppler measurement of resistive index
时间窗: Baseline
Ultrasound Doppler quantitative measurement of hepatic artery resistive index
Portal vein Doppler assessment of flow phasicity (monophasic, biphasic or triphasic)
时间窗: Baseline
Ultrasound Doppler assessment of portal vein flow phasicity (monophasic, biphasic or triphasic)
Portal vein quantitative Doppler measurement of maximum flow rate (cm/s)
时间窗: Baseline
Ultrasound Doppler quantitative measurement of portal vein maximum flow rate (cm/s)
Portal vein quantitative Doppler measurement of minimum flow rate (cm/s)
时间窗: 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)
时间窗: Baseline
Ultrasound Doppler quantitative measurement of portal vein pulsatility index
Portal vein quantitative Doppler measurement of flow volume (ml/s)
时间窗: Baseline
Ultrasound Doppler measurement of portal vein flow volume (ml/s)
次要结局
未报告次要终点
研究者
Pui Kwan Joyce Chan
Associate consultant radiologist, Deputy Head of Ultrasound team of radiology, Principle investigator
Hong Kong Children's Hospital