Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT05723705
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-27
First Post:
2023-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of a European Training Program for Robotic Liver Surgery (LIVEROBOT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-24', 'studyFirstSubmitDate': '2023-01-25', 'studyFirstSubmitQcDate': '2023-02-08', 'lastUpdatePostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Textbook Outcome in Liver Surgery (TOLS)', 'timeFrame': '30 days', 'description': 'TOLS is a novel composite measure that captures the most desirable surgical outcomes into a single indicator and is defined as the absence of intraoperative incidents of grade ≥ 2 (defined according to the Oslo classification), postoperative bile leakage of grade B or C (according to the severity grading of the International Study Group of Liver Surgery), Clavien-Dindo ≥ Grade 3 complications, 30-day readmission, in-hospital mortality and the presence of R0 resection margin.'}], 'secondaryOutcomes': [{'measure': 'CUSUM operative time (Learning curve)', 'timeFrame': 'After completion of 50 minor and 50 major robotic liver surgery cases per surgeon'}, {'measure': 'Textbook Outcome in Liver Surgery + (TOLS+)', 'timeFrame': '30 days', 'description': "TOLS+ is an extended definition of TOLS and includes the same variables as TOLS but adds 'prolonged LOS' defined as \\> 4 days for minor RLS and \\> 7 days for major RLS."}, {'measure': 'Performance grading using the modified OSATS score', 'timeFrame': '2 years (expected)', 'description': 'As assessed by the proctors through video-review'}, {'measure': 'Conversion to open surgery', 'timeFrame': 'at operation completion'}, {'measure': 'Estimated operative blood loss', 'timeFrame': 'at operation completion'}, {'measure': 'Blood transfusions', 'timeFrame': 'at operation completion'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Expected 4-10 days depending on if minor or major liver resection'}, {'measure': 'Intra-operative ICG-margin assessment', 'timeFrame': 'at operation completion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Diseases', 'Liver Neoplasm', 'Liver Cancer', 'Liver Metastases', 'Biliary Tract Cancer', 'Biliary Tract Neoplasms', 'Biliary Tract Diseases']}, 'descriptionModule': {'briefSummary': "LIVEROBOT is a collaboration of high-volume liver surgical centers in Europe (≥60 liver resections per year), supported by the European-African Hepato-Pancreato-Biliary Association Education Committee (E-AHPBA), and the European Registry of Minimally Invasive Liver Surgery (E-MILS) aiming to support the step-up implementation and safety of advanced surgical expertise of robotic liver surgery (RLS) on a European basis. The LIVEROBOT training program aims to promote the safe implementation of RLS throughout Europe. The data from all patients operated on during a surgeons' participation in the training program will be prospectively gathered allowing for learning curve and outcome analyses."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients are 18 years or above who are eligible to undergo a robotic hepatectomy for accepted indications.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Center/Surgeon Eligibility Criteria:\n\nPrior to admission to the LIVEROBOT training program surgeons must demonstrate laparoscopic experience with a laparoscopic cholecystectomy with OSATS score \\>3 (reviewed by proctors), participation in the LAELIVE training program or demonstrating more than two-year experience in clinical laparoscopic liver surgery. Additionally, a minimal surgical volume is required for participation. Annual liver surgery volume (open and minimally invasive combined) per two surgeons should be more 60, aiming to reach more than 40 RLS annually. Each participating surgeon should individually perform a minimum of more than 15 hepatectomy procedures annually. Surgeons shall be excluded from the training program if at any point failing to meet the minimal volume criteria (corrected for COVID-19 restrictions).\n\nInclusion Criteria:\n\n* Age equal or above 18 years\n* Eligible for elective minimally invasive and open hepatectomy for malignant, pre-malignant or benign disease located in the liver or biliary tract\n* Eligible for both minimally invasive and open surgery according to the operating surgeon\n* Fit to undergo the indicated operation according to both the anaesthesiologist and surgeon\n\nExclusion Criteria:\n\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05723705', 'acronym': 'LIVEROBOT', 'briefTitle': 'Impact of a European Training Program for Robotic Liver Surgery (LIVEROBOT)', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'Impact of a European Training Program for Robotic Liver Surgery (LIVEROBOT)', 'orgStudyIdInfo': {'id': 'LIVEROBOT'}, 'secondaryIdInfos': [{'id': 'W22_217 # 22.269', 'type': 'OTHER', 'domain': 'METC Amsterdam UMC'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'European Multicentre Training Program for Robotic Liver Surgery', 'type': 'OTHER', 'otherNames': ['Robotic Liver Surgery'], 'description': 'LIVEROBOT is a pan-european multicentre training program for robotic liver surgery involving simulation training, a procedure video-library, on and off-site proctoring, and video-assessment.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gabriela Pilz da Cunha, MD', 'role': 'CONTACT', 'email': 'g.pilzdacunha@amsterdamumc.nl', 'phone': '020 444 4444'}], 'overallOfficials': [{'name': 'Rutger-Jan Swijnenburg, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, {'name': 'Jeroen Hagendoorn, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}, {'name': "Mathieu d'Hondt, MD PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AZ Groeninge'}, {'name': 'Mohammed Abu Hilal, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poliambulanza Foundation Hospital Brescia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'collaborators': [{'name': 'UMC Utrecht', 'class': 'OTHER'}, {'name': 'General Hospital Groeninge', 'class': 'OTHER'}, {'name': 'Fondazione Poliambulanza Istituto Ospedaliero', 'class': 'OTHER'}, {'name': 'Intuitive Surgical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. R.J. (Rutger-Jan) Swijnenburg', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}