Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT04381702
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2020-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016577', 'term': 'Pancreaticoduodenectomy'}], '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': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-10', 'studyFirstSubmitDate': '2020-05-06', 'studyFirstSubmitQcDate': '2020-05-06', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morbimortality of Laparoscopic pancreaticoduodenectomy (LPD)', 'timeFrame': '90 postoperative days', 'description': 'Morbimortality of Laparoscopic pancreaticoduodenectomy (LPD) compared to the gold standard Open pancreaticoduodenectomy approach (OPD) :Overall morbidity (according to Clavien Dindo Classification)'}], 'secondaryOutcomes': [{'measure': 'Number of lymph nodes removed', 'timeFrame': '14 postoperative days', 'description': 'Number of lymph nodes removed'}, {'measure': 'Margins of excision', 'timeFrame': '14 postoperative days', 'description': 'Margins of excision R0, R1, R2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatoduodenectomy', 'Benign or malign pathology', 'Mini-invasive approach', 'Morbimortality', 'Laparoscopic approach'], 'conditions': ['Pancreatoduodenectomy']}, 'descriptionModule': {'briefSummary': 'Aim of the study :\n\nTo determine the morbimortality of Laparoscopic pancreaticoduodenectomy (LPD) compared to the gold standard Open pancreaticoduodenectomy approach (OPD).\n\nMethods :\n\nThis is a monocentric retrospective study based on a prospectively maintained clinical database. The study included 28 consecutive patients operated, between January 2016 and March 2019, of Laparoscopic pancreaticoduodenectomy (LPD) that we compared to 62 patients operated with the classical open approach by the same surgeon before the first laparoscopic resection at our institution.', 'detailedDescription': "The progress achieved over the last 20 years and the growing experience of visceral surgeons in minimally invasive surgery allow us today to embark on increasingly complex surgeries.\n\nLaparoscopic surgery has even become the gold standard approach for many interventions, whether for bariatric functional surgery, reflux surgery, pelvic static disorder surgery, but also for tumor surgery such as colorectal cancer, esophageal or tail of the pancreas.\n\nHowever, there are still interventions which, due to their technical difficulty, do not find unanimous consensus among the international scientific community for a possible minimally invasive approach.\n\nThe close contact of the pancreatic gland with the splenomesaraic trunk making laparoscopic dissection difficult with risk of uncontrollable bleeding.\n\nIt seems, however, that the finesse of the dissection and coagulation instruments and the precision of today's optics make it possible to approach the head of the pancreas in completely satisfactory conditions.\n\nSeveral centers around the world have developed the LPD technique with encouraging results in terms of perioperative mortality without showing any advantage over laparotomy.\n\nAt the Montpellier University Hospital we started performing Laparoscopic pancreaticoduodenectomy (LPD) at the beginning of 2016.\n\nThe aim of this study is to assess, on the one hand, the morbimortality and the quality of surgery linked to the development of this relatively new technique in a reference center for pancreatic surgery and on the other hand to assess a possible learning curve effect within our experience."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication\n\nExclusion criteria:\n\n-reject the study protocol'}, 'identificationModule': {'nctId': 'NCT04381702', 'acronym': 'PaMIvOP', 'briefTitle': 'Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy: a Single Surgeon Experience', 'orgStudyIdInfo': {'id': 'RECHMPL19_0253'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with an open approach', 'description': 'Patients requiring pancreatoduodenectomy and operated with an open approach : All consecutive patients requiring pancreato-duodenectomies for benign or malignant pathology before the first laparoscopic pancreaticoduodenectomy.', 'interventionNames': ['Procedure: Pancreatoduodenectomy']}, {'label': 'Patients with a laparoscopic approach', 'description': 'Patients requiring pancreatoduodenectomy and operated with a laparoscopic approach : All consecutive patients requiring pancreato-duodenectomies for benign or malignant pathology operated with a laparoscopic approach.', 'interventionNames': ['Procedure: Pancreatoduodenectomy']}], 'interventions': [{'name': 'Pancreatoduodenectomy', 'type': 'PROCEDURE', 'description': 'Open or laparoscopic pancreato-duodenectomy with pancreatojejunal anastomosis', 'armGroupLabels': ['Patients with a laparoscopic approach', 'Patients with an open approach']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'REGIS SOUCHE', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université Montpellier', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}