Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-26 @ 1:37 PM
Study NCT ID:
NCT03967067
Status:
COMPLETED
Last Update Posted:
2019-05-30
First Post:
2019-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors for Major Complications After Liver Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006498', 'term': 'Hepatectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-26', 'studyFirstSubmitDate': '2019-05-26', 'studyFirstSubmitQcDate': '2019-05-26', 'lastUpdatePostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '90-day Mortality rate', 'timeFrame': '90 days from surgery', 'description': 'Death within 90 days of surgical procedure'}, {'measure': '90-day Complication rate', 'timeFrame': '90 days from surgery', 'description': 'Defined by Clavien-Dindo grade I to IV within90 days of surgical procedure'}], 'secondaryOutcomes': [{'measure': 'Risk factor of major complication at 90-day', 'timeFrame': '90 days from surgery', 'description': 'defined by multivariate logistic regression of 90 day complication with Clavien-Dindo more than grade III'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Audit', 'Liver resection', 'Surgical complications', 'non-Eastern/non-Western', 'Quality improvement'], 'conditions': ['Liver Diseases']}, 'referencesModule': {'references': [{'pmid': '23461811', 'type': 'BACKGROUND', 'citation': 'Dokmak S, Fteriche FS, Borscheid R, Cauchy F, Farges O, Belghiti J. 2012 Liver resections in the 21st century: we are far from zero mortality. HPB (Oxford). 2013 Nov;15(11):908-15. doi: 10.1111/hpb.12069. Epub 2013 Mar 6.'}, {'pmid': '25322917', 'type': 'BACKGROUND', 'citation': 'Lim C, Dejong CH, Farges O; e-HPBchir Study Group from the Association de Chirurgie Hepato-Biliaire et de Transplantation (ACHBT) (Association of Hepatobilary and Transplant Surgery). Improving the quality of liver resection: a systematic review and critical analysis of the available prognostic models. HPB (Oxford). 2015 Mar;17(3):209-21. doi: 10.1111/hpb.12346. Epub 2014 Oct 17.'}, {'pmid': '26747223', 'type': 'BACKGROUND', 'citation': 'Benkabbou A, Souadka A, Serji B, Hachim H, Mohsine R, Ifrine L, Belkouchi A, El Malki HO. Changing paradigms in the surgical management of cystic liver hydatidosis improve the postoperative outcomes. Surgery. 2016 Apr;159(4):1170-80. doi: 10.1016/j.surg.2015.10.029. Epub 2015 Dec 31.'}, {'pmid': '22395347', 'type': 'BACKGROUND', 'citation': 'Galun DA, Bulajic P, Zuvela M, Basaric D, Ille T, Milicevic MN. Is there any benefit from expanding the criteria for the resection of hepatocellular carcinoma in cirrhotic liver? Experience from a developing country. World J Surg. 2012 Jul;36(7):1657-65. doi: 10.1007/s00268-012-1544-x.'}, {'pmid': '20662788', 'type': 'BACKGROUND', 'citation': 'Mann CD, Palser T, Briggs CD, Cameron I, Rees M, Buckles J, Berry DP. A review of factors predicting perioperative death and early outcome in hepatopancreaticobiliary cancer surgery. HPB (Oxford). 2010 Aug;12(6):380-8. doi: 10.1111/j.1477-2574.2010.00179.x.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the risk factors for major complications following liver resection in the setting of a general surgery-teaching department in Morocco, North Africa', 'detailedDescription': 'Over the past 20 years, the refinement of liver surgery techniques, anesthesiology and perioperative management has dramatically improved the safety of liver resection patients. It has also led to a concomitant extension of indications for a growing number of patients with complex benign or malignant hepatobiliary diseases and/or high risk surgeries.\n\nPublished complication rates and risk prediction models and recommendations for patients undergoing liver resection primarily stem from far East or Western high-volume specialized centers. In developing countries, including those in North Africa, specific constraints (e.g., endemic indications, such as liver cystic hydatidosis, blood shortage, and the scarcity of liver surgeons and intensive care providers) may impact liver resection outcomes but they are rarely addressed in the literature.\n\nThe aim of this study was to determine the risk factors for major complications following liver resection in the setting of a general surgery-teaching department in Morocco, North Africa'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patient who underwent a liver resection in a sugical hepatobiliary department and who had underwent preoperative serum tests, imaging workup and multidisciplinary discussion, according to the indication for LR. Adequate imaging assessment included the calculation of the future remnant liver volume (RLV) using free software, as needed. Preoperative portal embolization or a 2-step approach, including ALPPS, was considered in non-cirrhotic cases with a RLV to body weight ratio \\<0.5%', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients who underwent an hepatectomy\n* between january 2010 and December 2015\n\nExclusion Criteria:\n\n* All patient who only underwent liver biopsy with no resection\n* Patients non operated'}, 'identificationModule': {'nctId': 'NCT03967067', 'briefTitle': 'Risk Factors for Major Complications After Liver Resection', 'organization': {'class': 'OTHER', 'fullName': 'Moroccan Society of Surgery'}, 'officialTitle': 'Risk Factors for Major Complications After Liver Resection: Audit of a Non-Eastern/Non-Western Experience', 'orgStudyIdInfo': {'id': 'LiverResection'}}, 'armsInterventionsModule': {'interventions': [{'name': 'liver resection', 'type': 'PROCEDURE', 'description': 'Open or laparoscopic, major or minor hepatectomy performed using the clamp-crush technique and intermittent clamping of hepatic pedicle'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10100', 'city': 'Rabat', 'country': 'Morocco', 'facility': 'Ibn Sina Hospital, Surgical department A', 'geoPoint': {'lat': 34.01325, 'lon': -6.83255}}], 'overallOfficials': [{'name': 'Abdelkader Belkouchi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Surgical department A Ibn Sina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moroccan Society of Surgery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}