Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 6:21 AM
Study NCT ID:
NCT06874660
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2025-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Surgical Timing on Perioperative Clinical Outcomes in Pancreaticoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005402', 'term': 'Fistula'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-09', 'studyFirstSubmitDate': '2025-03-09', 'studyFirstSubmitQcDate': '2025-03-09', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cost of hospitalization', 'timeFrame': 'perioperative', 'description': 'Cost of surgery; cost of postoperative medications; total cost of hospitalization'}], 'primaryOutcomes': [{'measure': 'perioperative complication', 'timeFrame': 'perioperative', 'description': 'pancreatic fistula; postoperative bleeding; abdominal infection; delayed gastric emptying'}], 'secondaryOutcomes': [{'measure': 'Length of hospitalization', 'timeFrame': 'perioperative', 'description': 'Length of admission to surgery; length of surgery; length of postoperative stay to discharge'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreaticoduodenal; Fistula', 'Surgery Timing', 'Perioperative Complication']}, 'descriptionModule': {'briefSummary': 'With the advancement of surgical techniques and the increase in pancreatic oncologic diseases, the volume of pancreaticoduodenal surgeries has been increasing year by year in our center, and multiple pancreaticoduodenal surgeries are often performed on the day of surgery. This study will compare the effect of pancreaticoduodenal surgery performed at different times on patient prognosis. This study plans to divide the patients into morning group, afternoon group, and night group through the start time of surgery, and this study plans to analyze subgroups such as laparoscopic pancreaticoduodenal surgery. The outcome indicators include perioperative complications such as pancreatic fistula, bleeding, abdominal infection, hospitalization cost, and length of hospital stay. The conclusions drawn from this study will suggest to surgeons whether pancreaticoduodenal surgery performed at different times of the day will have different outcomes for patients and will guide surgeons on the timing of pancreaticoduodenal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who met the surgical guidelines for pancreaticoduodenectomy and underwent pancreaticoduodenectomy during the trial period', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must be required to sign an informed consent form;\n2. Age 18-80 years, male and female;\n3. ECOG Physical Status Score (PS Score) 0 or 1.\n4. Pancreaticoduodenectomy at our center without contraindications related to the surgery.\n\nExclusion Criteria:\n\n1. Pre-existing or concurrent other malignant tumors\n2. Severe cardiopulmonary and renal dysfunction.\n3. Autoimmune disease or history of immunodeficiency\n4. Active infections and infectious diseases requiring systemic therapy.\n5. History of psychotropic substance abuse, alcoholism or drug addiction.\n6. Failure to meet the inclusion criteria as determined by the investigator.'}, 'identificationModule': {'nctId': 'NCT06874660', 'briefTitle': 'Effects of Surgical Timing on Perioperative Clinical Outcomes in Pancreaticoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Influence of Timing on Outcomes of Pancreaticoduodenectomy: Complications, Hospital Costs, and Length of Stay', 'orgStudyIdInfo': {'id': '2025-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'surgery before 12.00 pm'}, {'label': '2', 'description': 'surgery before 12.00 pm'}]}, 'contactsLocationsModule': {'locations': [{'zip': '213000', 'city': 'Changzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Xinrui Zhu', 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Xinrui Zhu，MD', 'investigatorAffiliation': 'The Third Affiliated Hospital of Soochow University'}}}}