Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-30 @ 1:53 AM
Study NCT ID:
NCT01483859
Status:
COMPLETED
Last Update Posted:
2015-07-16
First Post:
2011-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Intraoperative Blood Loss and Postoperative Recovery by Liver Stiffness Measurement (Fibroscan®) in Right Hepatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-14', 'studyFirstSubmitDate': '2011-11-24', 'studyFirstSubmitQcDate': '2011-11-29', 'lastUpdatePostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The correlation between the value of liver stiffness measurement and intraoperative blood loss during right hepatectomy', 'timeFrame': 'Participants will be followed for perioperative period, approximate 6 weeks through chart review.', 'description': 'The investigators will investigate the value of liver stiffness measurement and intraoperative blood loss during right hepatectomy through chart review. The investigators will analyze the correlation between the value of liver stiffness measurement and intraoperative blood loss during right hepatectomy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Liver Malignancy']}, 'descriptionModule': {'briefSummary': 'Liver stiffness measurement (LSM) using Fibroscan®(EchoSens, Paris, France) is a newly introduced noninvasive tool that generates an elastic wave using a vibrator applied to the thoracic wall at the level of the right lobe of the liver and measures the prolongation velocity of the wave, which is directly associated with liver stiffness (LS). Although recent advances in surgical techniques and perioperative management have made with established perioperative management have now made it possible to perform hepatectomies as a safe procedure with minimum mortality, the possibility of massive blood loss and resultant transfusion during hepatectomy still exist. The objective of this research was to identify the role of liver stiffness measurement for the prediction of intraoperative blood loss and postoperative recovery after elective right hepatectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing right hepatectomy between August 2007 and July 2011\n\nExclusion Criteria:\n\n* patients undergoing right hepatectomy without preoperative liver stiffness measurement'}, 'identificationModule': {'nctId': 'NCT01483859', 'briefTitle': 'Prediction of Intraoperative Blood Loss and Postoperative Recovery by Liver Stiffness Measurement (Fibroscan®) in Right Hepatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Prediction of Intraoperative Blood Loss and Postoperative Recovery by Liver Stiffness Measurement (Fibroscan®) in Right Hepatectomy', 'orgStudyIdInfo': {'id': '1-2011-0053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'right hepatectomy with preoperative LSM', 'description': 'patients undergoing right hepatectomy with preoperative LSM between August 2007 and July 2011', 'interventionNames': ['Other: preoperative liver stiffness measurement']}], 'interventions': [{'name': 'preoperative liver stiffness measurement', 'type': 'OTHER', 'otherNames': ['Liver stiffness measurement (LSM) using Fibroscan®(EchoSens, Paris, France)'], 'description': 'Liver stiffness measurement (LSM) using Fibroscan is a newly introduced noninvasive tool that generates an elastic wave using a vibrator applied to the thoracic wall at the level of the right lobe of the liver and measures the prolongation velocity of the wave, which is directly associated with liver stiffness (LS).', 'armGroupLabels': ['right hepatectomy with preoperative LSM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jeong-Rim LEE', 'investigatorAffiliation': 'Yonsei University'}}}}