Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:29 AM
Study NCT ID:
NCT07414004
Status:
COMPLETED
Last Update Posted:
2026-02-17
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Prognosis Between Open Pancreatic Surgery With Vein Resection and Reconstruction Versus Minimally Invasive Pancreatic Surgery With Vein Resection and Reconstruction for Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2451}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidences of postoperative thrombosis', 'timeFrame': 'within 30 postoperative days'}, {'measure': 'incidences of major complication', 'timeFrame': 'within 30 postoperative days', 'description': 'Postoperative complications were defined and graded according to the Clavien-Dindo (C-D) classification system ranging from Grade I (minor deviation) to Grade V (death), with C-D ≥III being considerated as major complication'}], 'secondaryOutcomes': [{'measure': 'incidence of postoperative pancreatic fistula', 'timeFrame': 'within 30 postoperative days'}, {'measure': 'incidence of postoperative delayed gastric emptying', 'timeFrame': 'within 30 postoperative days'}, {'measure': 'incidence of postoperative post-pancreatectomy hemorrhage', 'timeFrame': 'within 30 postoperative days'}, {'measure': 'postoperative overall survival', 'timeFrame': 'before discharge, and at 3, 6, 12, 18, 24, 30, and 36 months postoperatively'}, {'measure': 'postoperative recurrence-free survival', 'timeFrame': 'before discharge, and at 3, 6, 12, 18, 24, 30, and 36 months postoperatively'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Tumor Patients Who Consecutively Underwent Minimally Invasive or Open Pancreatic Surgery With Venous Reconstruction']}, 'descriptionModule': {'briefSummary': 'The prognostic differences between open and minimally invasive radical pancreatic surgery combined with venous resection and reconstruction remain controversial, and there is a lack of high-quality evidence-based medical evidence to support either approach. Therefore, this study intends to conduct a retrospective cohort analysis, planning to enroll pancreatic cancer patients who have undergone radical pancreatic surgery (open vs. minimally invasive) combined with venous resection and reconstruction from multiple hospitals both domestically and internationally, and to collect relevant data. The primary objective is to evaluate the differences in postoperative thrombosis and the incidence of severe complications between the two groups. Furthermore, prognostic data will be collected to assess the impact of open versus minimally invasive pancreatic surgery combined with venous resection and reconstruction on both short-term and long-term all-cause mortality in pancreatic cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing pancreatic surgery combined with venous resection and reconstruction.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of malignant pancreatic or periampullary lesions requiring surgical pancreatic resection; preoperative imaging confirming venous involvement; undergoing pancreatic resection with simultaneous venous resection and reconstruction; and availability of complete postoperative outcome data, including thrombosis and complication grading.\n\nExclusion Criteria:\n\n* preoperative confirmation of distant metastasis.'}, 'identificationModule': {'nctId': 'NCT07414004', 'briefTitle': 'Comparison of Prognosis Between Open Pancreatic Surgery With Vein Resection and Reconstruction Versus Minimally Invasive Pancreatic Surgery With Vein Resection and Reconstruction for Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'Comparison of Prognosis Between Open Pancreatic Surgery With Vein Resection and Reconstruction Versus Minimally Invasive Pancreatic Surgery With Vein Resection and Reconstruction for Pancreatic Cancer: A Multicenter Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'ZXIIT2024234'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Open', 'description': 'The open pancreatic surgery with venous resection and reconstruction cohort'}, {'label': 'MIS', 'description': 'The minimally invasive pancreatic surgery with venous resection and reconstruction cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': "the First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}