Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-21 @ 12:42 AM
Study NCT ID:
NCT02569567
Status:
UNKNOWN
Last Update Posted:
2015-11-17
First Post:
2015-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Smart-Shear Wave Elastography and Transient Elastography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-14', 'studyFirstSubmitDate': '2015-10-05', 'studyFirstSubmitQcDate': '2015-10-05', 'lastUpdatePostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-inferiority of Smart-Shear Wave(SSW) imaging compared to Transient elastography(TE) in diagnosis for hepatic fibrosis.', 'timeFrame': '1 year', 'description': 'Applicability rate between Smart-Shear Wave(SSW) and Transient elastography(TE) will be compared to prove non-inferiority.\n\nApplicability rate = {\\[Total cases- (failure cases + non-reliable measurement cases)\\]/total case} \\* 100 (%)'}], 'secondaryOutcomes': [{'measure': 'Evaluation of diagnostic accuracy to predict the degree of hepatic fibrosis.', 'timeFrame': '1 year', 'description': 'Areas under the receiver operating curve (AUROCs) of the two techniques will be compared to estimate the probability of correctly predicting the degree of hepatic fibrosis.\n\nSubstantial discordance between US elastography techniques and histologic staging will also be explored. It is defined as a difference in fibrosis stage by at least 2 points.'}, {'measure': 'The correlation between two US elastography techniques', 'timeFrame': '1 year', 'description': "The correlation between the two US elastography techniques will be tested using the Spearman's correlation coefficient."}, {'measure': 'Reliability of Smart-Shear Wave(SSW) comparing diagnostic performance according to the reliable measurement index(RMI) results', 'timeFrame': '1 year', 'description': 'Reliable measurement index (RMI) is an reliability index that computes the reliability of the calculated stiffness by analyzing the changes in shapes of propagated shear waves. The diagnostic performance of Smart-Shear wave will be assessed by comparing the RMI result.'}, {'measure': 'Precision of Smart-Shear Wave(SSW)', 'timeFrame': '1 year', 'description': 'Precision of Smart-Shear Wave(SSW) will be assessed using the composite factors, including intraclass correlation coefficients (ICCs), within subject SD(wSD), repeatability coefficient(RC), and within subject CV(wCV).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smart-Shear Wave(SSW)', 'Transient Elastography(TE)', 'Liver cirrhosis'], 'conditions': ['Fibrosis, Liver']}, 'descriptionModule': {'briefSummary': 'The aim of this prospective study was to evaluate the applicability and diagnostic performances of Smart-Shear wave(SSW) imaging, in comparison with Transient elastography(TE) for the staging of liver fibrosis using pathologic results as the reference standard.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 105 participants will be enrolled. Participants are patients with liver disease who are planning to undergo liver surgery, and potential liver donors for living related liver transplantation.\n\nStudy population size was calculated by considering a power of 80%(1-sided alpha of 25%), and an expected dropout rate of 10%.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with liver disease: plan to undergo liver surgery\n2. Potential liver donors\n3. Smart-Shear wave \\& transient elastography were performed within one month from liver surgery\n4. Aged between 20 to 80 years\n5. Compliance with scheduled visits, evaluation plans and other study procedures\n\nExclusion Criteria:\n\n1. Previous history of hepatic surgery\n2. Previous history of transarterial chemoembolization\n3. Huge or infiltrative tumor in the right lobe of the liver\n4. Bile duct dilatation in the right lobe of the liver\n5. Older than 80 years\n6. The opinion of the investigator would make the patient unsuitable for enrollment'}, 'identificationModule': {'nctId': 'NCT02569567', 'acronym': 'SMART', 'briefTitle': 'Comparison of Smart-Shear Wave Elastography and Transient Elastography', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Applicability, Reliability and Accuracy for Staging Hepatic Fibrosis: Comparison of Smart-Shear Wave Elastography and Transient Elastography', 'orgStudyIdInfo': {'id': 'SMART15'}, 'secondaryIdInfos': [{'id': '2015-0782', 'type': 'OTHER', 'domain': 'Asan Medical Center Institution Review Board(IRB)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'US elastography', 'description': 'Participants who have the plan of liver transplantation or liver biopsy within 4 weeks will be screened from the outpatient clinic.\n\nTwo types of ultrasonographic elastography(US elastography) techniques including Smart-Shear Wave(SSW) imaging and transient elastography(TE) will be performed as a diagnostic method for hepatic fibrosis.', 'interventionNames': ['Procedure: Smart-Shear Wave(SSW) imaging', 'Procedure: Transient elastography(TE)']}], 'interventions': [{'name': 'Smart-Shear Wave(SSW) imaging', 'type': 'PROCEDURE', 'otherNames': ['S-Shearwave'], 'description': '1. All Smart-Shear Wave(SSW) imaging examinations will be performed by one operator.\n2. The right lobe of the liver is examined through the intercostal view with the patient lying in a supine or semi-decubitus position with the right arm in maximal abduction.\n3. Once the optimal sizes of the regions of interest is chosen, they are fixed for subsequent measurement in each subject. Special attention is paid to avoid any focal lesion, vessels, biliary tracts, or artifacts from nearby lung gas or cardiac movement.', 'armGroupLabels': ['US elastography']}, {'name': 'Transient elastography(TE)', 'type': 'PROCEDURE', 'otherNames': ['FibroScan®'], 'description': '1. Using the M probe in patients with BMI \\<30 kg/m2.\n2. Liver measurement is taken at either the seventh or eighth intercostal space of each subject over the right lobe of the liver. The measuring depth ranges from 2.5 to 6.5 cm below the skin surface.\n3. Examinations are performed by a sonographer blinded to S-shear wave elastography, and biological results.', 'armGroupLabels': ['US elastography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05505', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'So Yeon Kim, Dr', 'role': 'CONTACT', 'email': 'sykim.radiology@gmail.com', 'phone': '82-2-3010-5980'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'So Yeon Kim, Dr', 'role': 'CONTACT', 'email': 'sykim.radiology@gmail.com', 'phone': '82-2-3010-5980'}, {'name': 'So Hyun Park, Dr', 'role': 'CONTACT', 'email': 'nnoleeter@naver.com', 'phone': '82-2-3010-1497'}], 'overallOfficials': [{'name': 'So Yeon Kim, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'So Yeon Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}