Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 10:55 PM
Study NCT ID:
NCT05139394
Status:
COMPLETED
Last Update Posted:
2021-12-01
First Post:
2021-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emergency Pancreaticoduodenectomy: a Non-trauma Center Case Series
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-30', 'studyFirstSubmitDate': '2021-09-29', 'studyFirstSubmitQcDate': '2021-11-30', 'lastUpdatePostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative blood loss', 'timeFrame': 'The length of the surgical intervention (an average of 3 hours)', 'description': 'ml of blood'}, {'measure': 'Operative time', 'timeFrame': 'The length of the surgical intervention (an average of 3 hours)', 'description': 'minutes of operating time'}, {'measure': 'In-hospital Morbidity', 'timeFrame': 'Up to 90 days. Through study completion, during the hospital admission period'}, {'measure': 'In-hospital Mortality', 'timeFrame': 'Up to 90 days. Through study completion, during the hospital admission period'}, {'measure': 'Long-term evolution', 'timeFrame': 'The date of the last follow-up information was August 2021', 'description': 'It will be measured the overall survival time, number of readmissions and number of reinterventions'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emergencies', 'Pancreas Disease']}, 'descriptionModule': {'briefSummary': 'Pancreaticoduodenectomy is a challenging procedure itself, being even more complex and demanding in emergency settings. Only a few cases of emergency pancreaticoduodenectomy (EPD) are reported in medical literature, usually performed for complex pancreaticoduodenal lesions. EPD has first been mentioned in trauma settings, even fewer cases being reported for non-traumatic indications. The investigators intend to present our experience with this intervention, in a non-trauma surgical centre. Our study is a prospective consecutive case series, that included patients that underwent emergency pancreaticoduodenectomy from January 2014 to May 2021. Data was collected from the electronic system database. The investigators collected data regarding the demographic characteristics of the patients, their medical history, preoperative and postoperative investigations (including blood work and imagistic investigations), surgery related information and postoperative evolution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients operated in Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor Cluj-Napoca January 2014 and May 2021', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Emergency pancreaticoduodenectomy performed\n\nExclusion Criteria:\n\n* Elective surgery\n* Insufficient data'}, 'identificationModule': {'nctId': 'NCT05139394', 'briefTitle': 'Emergency Pancreaticoduodenectomy: a Non-trauma Center Case Series', 'organization': {'class': 'OTHER', 'fullName': 'Iuliu Hatieganu University of Medicine and Pharmacy'}, 'officialTitle': 'Emergency Pancreaticoduodenectomy: a Non-trauma Center Case Series', 'orgStudyIdInfo': {'id': 'EPD - CS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'emergency pancreaticoduodenectomy', 'type': 'PROCEDURE', 'description': 'Emergency pancreaticoduodenectomy (EPD) is a complex surgical procedure, that can be performed for complex pancreaticoduodenal injuries, that cannot be controlled through less invasive procedures. EPD can be performed either as a classical Whipple procedure, or as a pylorus-preserving procedure. A one stage procedure implies the reconstruction step being done in the same surgical intervention, while a two step procedure implies the reconstruction being done in a later stage, through a second surgical intervention.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iuliu Hatieganu University of Medicine and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Diana Schlanger', 'investigatorAffiliation': 'Iuliu Hatieganu University of Medicine and Pharmacy'}}}}