Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-27 @ 6:56 AM
Study NCT ID:
NCT04619966
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2020-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Measurements of Hepatic Vasculatures and Hepatic Doppler Assessment of Healthy Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2020-10-29', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatic veins diameter (in mm) measured by grey scale ultrasound at 1 - 2 cm from confluence with inferior vena cava', 'timeFrame': 'Baseline', 'description': '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'}, {'measure': 'Hepatic veins Doppler assessment of flow direction (towards or away from inferior vena cava)', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler assessment of right, middle and left hepatic veins for flow direction (towards or away from inferior vena cava)'}, {'measure': 'Hepatic veins Doppler assessment of flow pulsatility (yes or no)', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler assessment of right, middle and left hepatic veins for flow pulsatility (yes or no)'}, {'measure': 'Hepatic veins Doppler assessment of flow phasicity (monophasic, biphasic or triphasic)', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler assessment of right, middle and left hepatic veins for flow phasicity (monophasic, biphasic or triphasic)'}, {'measure': 'Hepatic veins Quantitative Doppler measurement of maximum flow rate (cm/s)', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler quantitative measurement of right, middle and left hepatic veins maximum flow rate (cm/s)'}, {'measure': 'Hepatic veins Quantitative Doppler measurement of minimum flow rate (cm/s)', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler quantitative measurement of right, middle and left hepatic veins minimum flow rate (cm/s)'}, {'measure': 'Hepatic veins Quantitative Doppler measurement of pulsatility index (only if pulsatility is present)', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler quantitative measurement of right, middle and left hepatic veins pulsatility index (Only if pulsatility is present)'}, {'measure': 'Hepatic artery diameter (in mm) measured by grey scale ultrasound at liver hilum', 'timeFrame': 'Baseline', 'description': 'Hepatic artery diameter (in mm) measured by grey scale ultrasound at the hepatic hilum (longitudinal axis)'}, {'measure': 'Hepatic artery Doppler assessment of flow direction (hepatofugal or hepatopetal)', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler assessment of hepatic artery flow direction (hepatofugal or hepatopetal)'}, {'measure': 'Hepatic artery Doppler assessment of flow pulsatility (yes or no)', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler assessment of hepatic artery flow pulsatility (yes or no)'}, {'measure': 'Hepatic artery Doppler assessment of flow phasicity (monophasic, biphasic or triphasic)', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler assessment of hepatic artery flow phasicity (monophasic, biphasic or triphasic)'}, {'measure': 'Hepatic artery quantitative Doppler measurement of peak systolic velocity (cm/s)', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler quantitative measurement of hepatic artery peak systolic velocity (cm/s)'}, {'measure': 'Hepatic artery quantitative Doppler measurement of end diastolic velocity (cm/s)', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler quantitative measurement of hepatic artery end diastolic velocity (cm/s)'}, {'measure': 'Hepatic artery quantitative Doppler measurement of pulsatility index', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler quantitative measurement of hepatic artery pulsatility index'}, {'measure': 'Hepatic artery quantitative Doppler measurement of resistive index', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler quantitative measurement of hepatic artery resistive index'}, {'measure': 'Hepatic artery quantitative Doppler measurement of flow volume (ml/s) (measured if feasible)', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler quantitative measurement of hepatic artery flow volume (ml/s)'}, {'measure': 'Portal vein diameter (in mm) measured by grey scale ultrasound at liver hilum', 'timeFrame': 'Baseline', 'description': 'Portal vein diameter (in mm) measured by grey scale ultrasound at liver hilum (longitudinal axis)'}, {'measure': 'Portal vein Doppler assessment of flow direction (hepatopetal or hepatofugal)', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler assessment of portal vein flow direction (hepatopetal or hepatofugal)'}, {'measure': 'Portal vein Doppler assessment of flow pulsatility (yes or no)', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler assessment of portal vein pulsatility (yes or no)'}, {'measure': 'Portal vein Doppler assessment of flow phasicity (monophasic, biphasic or triphasic)', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler assessment of portal vein flow phasicity (monophasic, biphasic or triphasic)'}, {'measure': 'Portal vein quantitative Doppler measurement of maximum flow rate (cm/s)', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler quantitative measurement of portal vein maximum flow rate (cm/s)'}, {'measure': 'Portal vein quantitative Doppler measurement of minimum flow rate (cm/s)', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler measurement of portal vein minimum flow rate (cm/s)'}, {'measure': 'Portal vein quantitative Doppler measurement of pulsatility index (only if pulsatility is present)', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler quantitative measurement of portal vein pulsatility index'}, {'measure': 'Portal vein quantitative Doppler measurement of flow volume (ml/s)', 'timeFrame': 'Baseline', 'description': 'Ultrasound Doppler measurement of portal vein flow volume (ml/s)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Portal Vein', 'Hepatic Veins', 'Hepatic Artery', 'Liver Circulation']}, 'referencesModule': {'references': [{'pmid': '2392362', 'type': 'BACKGROUND', 'citation': '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': '19409745', 'type': 'BACKGROUND', 'citation': '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': '6981312', 'type': 'BACKGROUND', 'citation': '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': '10882252', 'type': 'BACKGROUND', 'citation': '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': '1566656', 'type': 'BACKGROUND', 'citation': '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': '11214676', 'type': 'BACKGROUND', 'citation': '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': '1509050', 'type': 'BACKGROUND', 'citation': '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': '28759025', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nIn 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.\n\nTaking 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.\n\nThis may be related to the lack of a robust age corrected normal range of measurement for reference.\n\nExisting 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.\n\nIn 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.\n\nFlow patterns, including qualitative assessment and quantitative measurements of resistive index and flow velocities will also be assessed.\n\nThese 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.", 'detailedDescription': "Trial Objectives and Purpose:\n\n1. To establish normal limits of diameter of hepatic vein, hepatic artery and portal vein according to age, weight, height and gender.\n2. To establish normal waveform pattern in ultrasound Doppler assessment of hepatic vein, hepatic artery and portal vein. (Qualitative analysis)\n3. 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.\n\nTrial Design:\n\nA prospective cross-section observational study.\n\nRecruitment of study subjects:\n\nPatients 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.\n\nTreatment of subjects:\n\nRecruited 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.\n\nAll 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.\n\nStatistical method to be employed:\n\nContinuous 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.\n\nComparisons will be done by student's t-test. Relations between height, weight and gender with vessels diameter will be tested by Pearson correlation.\n\nLinear multiple regression analysis will be utilized with vessels diameter as the dependent variable.\n\nNumber of subject to be enrolled (observation study): 300\n\nRationale:\n\nSample size = (Standard normal variate)2 X (Standard deviation)2 / Presicion2 Sample size = 1.962 X 22 / 12 Sample size = 15.37\n\nStandard normal variate = 1.96 at 5% Type I error Standard deviation = up to 2mm (from prior study of portal vein diameter) Precision = 1mm\n\nIn 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.\n\nTarget to include 300 children in this study.\n\nAge groups:\n\nAround 30 cases for each of the following age groups:\n\n1. 0 - 1 years old\n2. 1 - 2 years old\n3. 2 - 4 years old\n4. 4 - 6 years old\n5. 6 - 8 years old\n6. 8 - 10 years old\n7. 10 - 12 years old\n8. 12 - 14 years old\n9. 14 - 16 years old\n10. 16- 18 years old"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients attending Hong Kong Children's Hospital for clinically indicated USG examination will be invited to participate in this study.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient \\< / = 18 years of age.\n2. No history of hepatobiliary nor cardiac pathology as checked with record in ePR. Verbal confirmation will be done with patient or parent / legal guardian.\n3. Attending USG study other than that of the hepatobiliary system. (ie. Patients attending for thyroid USG, urinary system USG, musculoskeletal system USG etc.)\n\nExclusion Criteria:\n\n1. Patient \\> 18 years of age\n2. Known history of hepatobiliary or cardiac pathology.\n3. Unstable patients.\n4. Intolerance of USG examination\n5. Uncooperative patients.\n6. Patient requiring sedation for USG study.'}, 'identificationModule': {'nctId': 'NCT04619966', 'briefTitle': 'Ultrasound Measurements of Hepatic Vasculatures and Hepatic Doppler Assessment of Healthy Children', 'organization': {'class': 'OTHER', 'fullName': "Hong Kong Children's Hospital"}, 'officialTitle': 'Ultrasound Measurements of Hepatic Vasculatures and Hepatic Doppler Assessment of Healthy Children', 'orgStudyIdInfo': {'id': 'HKCHUSG01'}}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Joyce Pui Kwan Chan, MBChB', 'role': 'CONTACT', 'email': 'cpk706@ha.org.hk', 'phone': '+85296362929'}], 'facility': "Hong Kong Children's Hospital", 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Pui Kwan Joyce Chan, MBChB', 'role': 'CONTACT', 'email': 'cpk706@ha.org.hk', 'phone': '+85296362929'}], 'overallOfficials': [{'name': 'Pui Kwan Joyce Chan, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Hong Kong Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hong Kong Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate consultant radiologist, Deputy Head of Ultrasound team of radiology, Principle investigator', 'investigatorFullName': 'Pui Kwan Joyce Chan', 'investigatorAffiliation': "Hong Kong Children's Hospital"}}}}