Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-28 @ 1:31 AM
Study NCT ID:
NCT06135233
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation and Outcome of Minimally Invasive Pancreatoduodenectomy in Europe:
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1336}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2023-11-13', 'studyFirstSubmitQcDate': '2023-11-13', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major morbidity', 'timeFrame': '30 days'}, {'measure': '30-day/in-hospital mortality.', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['registry', 'minimally invasive surgery', 'robot-assisted', 'laparoscopy', 'pancreatoduodenectomy', 'pancreatic surgery'], 'conditions': ['Pancreas Disease']}, 'descriptionModule': {'briefSummary': 'A planned analysis of outcomes among consecutive patients after MIPD from centers participating in the E-MIPS registry (2019-2021). Main outcomes of interest were major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality.', 'detailedDescription': 'The European registry for Minimally Invasive Pancreatic Surgery (E-MIPS) is an E-AHPBA endorsed registry with the aim to monitor and safeguard the introduction of MIPD in Europe. International multicenter audit-based studies focusing on outcomes of minimally invasive pancreatoduodenectomy (MIPD) are lacking.\n\nA planned analysis of outcomes among consecutive patients after MIPD from centers participating in the E-MIPS registry (2019-2021). Main outcomes of interest were major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Data from all patients who underwent R-MIPD and L-MIPD between January 1st 2019 and December 31st 2021 were included', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Data from all patients who underwent R-MIPD and L-MIPD between January 1st 2019 and December 31st 2021 were included\n\nExclusion Criteria:\n\n* Other pancreatic procedures\n* Hybrid approaches (reconstruction phase open)\n* Procedures with insufficient baseline data / missing primary outcome data.'}, 'identificationModule': {'nctId': 'NCT06135233', 'acronym': 'E-MIPS', 'briefTitle': 'Implementation and Outcome of Minimally Invasive Pancreatoduodenectomy in Europe:', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Implementation and Outcome of Minimally Invasive Pancreatoduodenectomy in Europe: A Critical Appraisal of the First 3 Years of the E-MIPS Registry', 'orgStudyIdInfo': {'id': 'NP5626'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'all patients undergoing minimally invasive pancreatic surgery, no intervention, no randomization'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105 AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Amsterdam UMC, locatie AMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'M.G. Besselink', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}