Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT01237002
Status:
COMPLETED
Last Update Posted:
2010-11-09
First Post:
2010-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pringle Time Exceeding 120 Min in Liver Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-08', 'studyFirstSubmitDate': '2010-11-08', 'studyFirstSubmitQcDate': '2010-11-08', 'lastUpdatePostDateStruct': {'date': '2010-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Liver ischemia; Pringle time'], 'conditions': ['Tolerance of the Liver']}, 'referencesModule': {'references': [{'pmid': '10077049', 'type': 'BACKGROUND', 'citation': 'Belghiti J, Noun R, Malafosse R, Jagot P, Sauvanet A, Pierangeli F, Marty J, Farges O. Continuous versus intermittent portal triad clamping for liver resection: a controlled study. Ann Surg. 1999 Mar;229(3):369-75. doi: 10.1097/00000658-199903000-00010.'}, {'pmid': '1998862', 'type': 'BACKGROUND', 'citation': 'Elias D, Desruennes E, Lasser P. Prolonged intermittent clamping of the portal triad during hepatectomy. Br J Surg. 1991 Jan;78(1):42-4. doi: 10.1002/bjs.1800780115.'}, {'pmid': '21975322', 'type': 'DERIVED', 'citation': 'Torzilli G, Procopio F, Donadon M, Del Fabbro D, Cimino M, Montorsi M. Safety of intermittent Pringle maneuver cumulative time exceeding 120 minutes in liver resection: a further step in favor of the "radical but conservative" policy. Ann Surg. 2012 Feb;255(2):270-80. doi: 10.1097/SLA.0b013e318232b375.'}]}, 'descriptionModule': {'briefSummary': "Intermittent Pringle's maneuver is widely used to limit blood loss during hepatectomy, without an established time-limit. However, many authors claims its danger for patients' outcome. The investigators check the short term outcome of a consecutive cohort of patients who underwent hepatectomy with intermittent clamping exceeding 120 minutes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '29 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Among 426 consecutive patients who underwent hepatectomy, we retrospectively selected 189 patients with clamping time exceeded 60 minutes: 117 having intermittent Pringle maneuver less 120 minutes and 72 having clamping time exceeding 120 minutes were analysed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients in whom total cumulative clamping time exceeded 60 minutes.\n\nExclusion Criteria:\n\n* patients in whom total cumulative clamping time was less than 60 minutes'}, 'identificationModule': {'nctId': 'NCT01237002', 'briefTitle': 'Pringle Time Exceeding 120 Min in Liver Resection', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'Safety of Intermittent Pringle Maneuver Cumulative Time Exceeding 120 Min in Liver Resection', 'orgStudyIdInfo': {'id': 'Pringle 120 minutes'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': '117 patients with cumulative clamping time between 60 and 120 minutes'}, {'label': 'Group 2', 'description': '72 patients with cumulative clamping time longer than 120 minutes'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'overallOfficials': [{'name': 'Guido Torzilli, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Humanitas Research Hospital IRCCS, Rozzano-Milan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Guido Torzilli, MD, PhD', 'oldOrganization': 'Liver Surgery Unit, Third Department of Surgery, University of Milan, IRCCS Istituto Clinico Humanitas'}}}}