Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
Study NCT ID:
NCT03791450
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2018-12-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of Pancreaticoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10085}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-01', 'studyFirstSubmitDate': '2018-12-21', 'studyFirstSubmitQcDate': '2018-12-28', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Postoperative Pancreatic Fistula(POPF)', 'timeFrame': 'Within 30 days after surgery', 'description': 'The frequency of POPF occurs and the POPF will be strictly diagnosis and classified according to IGSPF criteria.'}], 'secondaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': 'Within 90 days after surgery', 'description': 'The incidence of operative complications within 90 days after surgery'}, {'measure': 'Mortality', 'timeFrame': 'Within 30 days after surgery', 'description': 'The death occurred within 30 days after surgery'}, {'measure': 'Duration of operation', 'timeFrame': 'Intraoperative', 'description': 'The time of operation count by minute.'}, {'measure': 'Length of hospital stay after surgery', 'timeFrame': 'From first day after surgery to release from hospital (anticipate 5 days minimally)', 'description': 'Days between surgery and hospital discharge'}, {'measure': 'Hospital costs', 'timeFrame': 'From first day after surgery to release from hospital (anticipate 5 days minimally)', 'description': 'The total hospitalization expenses'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreaticoduodenectomy']}, 'descriptionModule': {'briefSummary': 'The investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique.', 'detailedDescription': 'For patients with malignant or benign disease of the pancreatic head and periampullary region, pancreaticoduodenectomy is the only potential approach to radical cure. However, pancreaticoduodenectomy is consider as one of the most complex operations associated with a high rate of postoperative complications such as pancreatic fistula, delayed gastric emptying, hemorrhage, abscess, and sepsis. These complications increase the costs associated with pancreaticoduodenectomy. Numerous interventions and techniques have been introduced to decrease the morbidity. But there is little evidence for the superiority of one anastomotic technique over the others. Therefore, investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had underwent pancreaticoduodenectomy between 2008 to 2018.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients who had underwent pancreaticoduodenectomy between 2008 to 2018.\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT03791450', 'briefTitle': 'Investigation of Pancreaticoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'A Multicenter Big⁃Sample Retrospective Study of Pancreaticoduodenectomy', 'orgStudyIdInfo': {'id': 'C201812'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pancreaticoduodenectomy', 'description': 'patients underwent pancreaticoduodenectomy in recent ten years.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Chen Xiaoping', 'investigatorAffiliation': 'Tongji Hospital'}}}}