Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2026-02-24 @ 1:15 AM
Study NCT ID:
NCT05520606
Status:
COMPLETED
Last Update Posted:
2022-08-30
First Post:
2022-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Pancreatoduodenectomy Versus Open Pancreatoduodenectomy
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': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-29', 'studyFirstSubmitDate': '2022-08-19', 'studyFirstSubmitQcDate': '2022-08-29', 'lastUpdatePostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative length of stay', 'timeFrame': 'up to 90 days', 'description': 'defined as the time from being admitted to hospital to discharge'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'through study completion, an average of 5 year', 'description': 'defined as the duration from the first day after surgery to either the date of death or the last follow-up'}, {'measure': 'Operation time', 'timeFrame': 'intraoperative', 'description': 'defined as the time from skin incision or trocar placement to complete skin closure'}, {'measure': 'postoperative complications', 'timeFrame': 'up to 90 days', 'description': 'Postoperative complications were reviewed within 90 days after surgery and graded according to Clavien-Dindo (CD) classification system. Postoperative biliary leakage, hemorrhage, and liver failure. Wound infection was defined as purulent drainage from the incision or/and positive findings of culture of the fluid or tissue aseptically obtained from the incision.'}, {'measure': 'Reoperation within 90 days', 'timeFrame': 'up to 90 days', 'description': 'defined as any reoperation within 90 days'}, {'measure': 'Mortality', 'timeFrame': 'up to 90 days', 'description': 'defined as any death within 30 days and 90 days, respectively'}, {'measure': 'Readmission within 90 days', 'timeFrame': 'up to 90 days', 'description': 'defined as any readmission within 90 days'}, {'measure': 'R0 resection', 'timeFrame': 'intraoperative', 'description': 'defined as tumor-free margins in all the reported surgical margins (biliary and circumferential margins'}, {'measure': 'Intraoperative blood loss', 'timeFrame': 'intraoperative', 'description': 'recorded by the anesthetist using a vacuum system'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laparoscopic', 'minimally invasive', 'open resection', 'Pancreatoduodenectomy'], 'conditions': ['Resectable Lesions Located in the Pancreatic Head or Periampullary Region']}, 'descriptionModule': {'briefSummary': 'This is a single, retrospective, real-world study to investigate the surgical outcomes of minimally invasive pancreatoduodenectomy and open pancreatoduodenectomy, with the perioperative characteristics and long-term overall survival being compared. The investigators aimed to find out whether the minimally invasive surgery is safe and feasible for resectable lesions located in the pancreatic head and periampullary region. And the investigators also want to find out patients with what kind of characteristic can be benefit from the minimally invasive surgery compared with the open approach.', 'detailedDescription': 'Pancreatoduodenectomy (Whipple surgery) is a complex surgical procedure and has been accepted as the gold standard treatment for resectable lesions of the pancreatic head and periampullary region.To date, how surgeons can safely pass the learning curve of laparoscopic pancreatoduodenectomy (LPD) without potentially harming patients remains a question. Around this topic, the investigators designed real-world study in a single center to retrospectively collect the PD surgeries since July 2014. The investigators aimed to find out whether the minimally invasive surgery is safe and feasible for resectable lesions located in the pancreatic head and periampullary region. And the investigators also want to find out patients with what kind of characteristic can be benefit from the minimally invasive surgery compared with the open approach. Besides, the investigators also want to investigate the clinical characteristics of patients and perioperative outcomes of LPD procedures and aimed to develop and validate a difficulty scoring system for patient selection which could help facilitate a comprehensive and security understanding of LPD for surgeon during different stage of the learning curve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent PD surgeries in Tongji Hospital since January 2014 .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 to 80 years.\n2. Patients underwent PD surgeries.\n\nExclusion Criteria:\n\n1. Peritoneal seeding or metastasis to distant sites;\n2. Incomplete clinical data.'}, 'identificationModule': {'nctId': 'NCT05520606', 'briefTitle': 'Laparoscopic Pancreatoduodenectomy Versus Open Pancreatoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Minimally Invasive Versus Open for Pancreatoduodenectomy：an Retrospective, Observational, Multicenter Real-world Study', 'orgStudyIdInfo': {'id': 'TJDBPS11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'minimally invasive surgery', 'description': 'laparoscopic pancreatoduodenectomy.', 'interventionNames': ['Procedure: pancreatoduodenectomy']}, {'label': 'open surgery', 'description': 'open pancreatoduodenectomy', 'interventionNames': ['Procedure: pancreatoduodenectomy']}], 'interventions': [{'name': 'pancreatoduodenectomy', 'type': 'PROCEDURE', 'description': 'Pancreatoduodenectomy (Whipple surgery) is a complex surgical procedure and has been accepted as the gold standard treatment for resectable lesions of the pancreatic head and periampullary region', 'armGroupLabels': ['minimally invasive surgery', 'open surgery']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Surgery, Chief Physician, Director of Surgical Supervision Department, Deputy Director of Institute of Hepatobiliary&Pancreatic, Director of Department of Biliary-Pancreatic Surgery', 'investigatorFullName': 'Renyi Qin', 'investigatorAffiliation': 'Tongji Hospital'}}}}