Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT07293104
Status:
COMPLETED
Last Update Posted:
2025-12-24
First Post:
2025-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Children in Pancreatic Surgery: Indications, Procedures and Outcomes
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 761}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-12-05', 'studyFirstSubmitQcDate': '2025-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality rate', 'timeFrame': '30 days', 'description': 'Perioperative death'}], 'secondaryOutcomes': [{'measure': 'Complication rates', 'timeFrame': '30 days', 'description': 'Perioperative surgical-related complication'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chidren', 'Pancreatic surgery', 'Surgical outcomes'], 'conditions': ['Pancreatic Surgery', 'Children']}, 'descriptionModule': {'briefSummary': 'Pediatric patients differ in a variety of properties from adult populations, but comprehensive multicenter or population-based data is missing for pancreatic surgery. This study aimed to evaluate indications, complications, and mortality in pediatric pancreatic surgery.', 'detailedDescription': 'This retrospective observational population-based cohort study analzes the German Diagnostic-Related Group database and included all children with pancreatic procedures between 2010 and 2023. The primary outcomes are mortality rates, complication rates, and sex differences related to surgical indication and pancreatic procedure. Descriptive epidemiological and multivariable regression analyses are performed to identify risk factors of mortality and occurrence of perioperative complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All persons addmitted to a German hospital between 2010 and 2023. Population-based dataset.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stationary hospital admission\n* pancreatic surgical procedure\n\nExclusion Criteria:\n\n* unknown sex or age\n* admission for pancreas tranplantation'}, 'identificationModule': {'nctId': 'NCT07293104', 'acronym': 'ChiPS', 'briefTitle': 'Children in Pancreatic Surgery: Indications, Procedures and Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Medizinische Hochschule Brandenburg Theodor Fontane'}, 'officialTitle': 'Children in Pancreatic Surgery', 'orgStudyIdInfo': {'id': 'ChiPS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pancreatic tumor', 'interventionNames': ['Procedure: Pancreatoduodenectomy', 'Procedure: Total pancreatectomy', 'Procedure: Distal pancreatectomy', 'Procedure: Anastomosis of the pancreatic duct', 'Procedure: Incision of the pancreas', 'Procedure: Internal drainage of the pancreas', 'Procedure: Local excision destruction pancreas', 'Procedure: Marsupialization of a pancreatic cyst', 'Procedure: Segmental pancreatic resection']}, {'label': 'Chronic pancreatitis', 'interventionNames': ['Procedure: Pancreatoduodenectomy', 'Procedure: Total pancreatectomy', 'Procedure: Distal pancreatectomy', 'Procedure: Anastomosis of the pancreatic duct', 'Procedure: Incision of the pancreas', 'Procedure: Internal drainage of the pancreas', 'Procedure: Local excision destruction pancreas', 'Procedure: Marsupialization of a pancreatic cyst', 'Procedure: Segmental pancreatic resection']}, {'label': 'Trauma', 'interventionNames': ['Procedure: Pancreatoduodenectomy', 'Procedure: Total pancreatectomy', 'Procedure: Distal pancreatectomy', 'Procedure: Anastomosis of the pancreatic duct', 'Procedure: Incision of the pancreas', 'Procedure: Internal drainage of the pancreas', 'Procedure: Local excision destruction pancreas', 'Procedure: Marsupialization of a pancreatic cyst', 'Procedure: Segmental pancreatic resection']}, {'label': 'Extra-pancreatic neoplasm', 'interventionNames': ['Procedure: Pancreatoduodenectomy', 'Procedure: Total pancreatectomy', 'Procedure: Distal pancreatectomy', 'Procedure: Anastomosis of the pancreatic duct', 'Procedure: Incision of the pancreas', 'Procedure: Internal drainage of the pancreas', 'Procedure: Local excision destruction pancreas', 'Procedure: Marsupialization of a pancreatic cyst', 'Procedure: Segmental pancreatic resection']}, {'label': 'Other diseases', 'interventionNames': ['Procedure: Pancreatoduodenectomy', 'Procedure: Total pancreatectomy', 'Procedure: Distal pancreatectomy', 'Procedure: Anastomosis of the pancreatic duct', 'Procedure: Incision of the pancreas', 'Procedure: Internal drainage of the pancreas', 'Procedure: Local excision destruction pancreas', 'Procedure: Marsupialization of a pancreatic cyst', 'Procedure: Segmental pancreatic resection']}], 'interventions': [{'name': 'Pancreatoduodenectomy', 'type': 'PROCEDURE', 'description': 'Procedure codes: 5-524.1; 5-524.2; 5-524.3', 'armGroupLabels': ['Chronic pancreatitis', 'Extra-pancreatic neoplasm', 'Other diseases', 'Pancreatic tumor', 'Trauma']}, {'name': 'Total pancreatectomy', 'type': 'PROCEDURE', 'description': 'Procedure codes: 5-525.\\*', 'armGroupLabels': ['Chronic pancreatitis', 'Extra-pancreatic neoplasm', 'Other diseases', 'Pancreatic tumor', 'Trauma']}, {'name': 'Distal pancreatectomy', 'type': 'PROCEDURE', 'description': 'Procedure code: 5-524.0', 'armGroupLabels': ['Chronic pancreatitis', 'Extra-pancreatic neoplasm', 'Other diseases', 'Pancreatic tumor', 'Trauma']}, {'name': 'Anastomosis of the pancreatic duct', 'type': 'PROCEDURE', 'description': 'Procedure codes: 5-527.\\*', 'armGroupLabels': ['Chronic pancreatitis', 'Extra-pancreatic neoplasm', 'Other diseases', 'Pancreatic tumor', 'Trauma']}, {'name': 'Incision of the pancreas', 'type': 'PROCEDURE', 'description': 'Procedure codes: 5-520.\\*', 'armGroupLabels': ['Chronic pancreatitis', 'Extra-pancreatic neoplasm', 'Other diseases', 'Pancreatic tumor', 'Trauma']}, {'name': 'Internal drainage of the pancreas', 'type': 'PROCEDURE', 'description': 'Procedure codes: 5-523.\\*', 'armGroupLabels': ['Chronic pancreatitis', 'Extra-pancreatic neoplasm', 'Other diseases', 'Pancreatic tumor', 'Trauma']}, {'name': 'Local excision destruction pancreas', 'type': 'PROCEDURE', 'description': 'Procedure codes: 5-521.\\*', 'armGroupLabels': ['Chronic pancreatitis', 'Extra-pancreatic neoplasm', 'Other diseases', 'Pancreatic tumor', 'Trauma']}, {'name': 'Marsupialization of a pancreatic cyst', 'type': 'PROCEDURE', 'description': 'Procedure codes: 5-522.\\*', 'armGroupLabels': ['Chronic pancreatitis', 'Extra-pancreatic neoplasm', 'Other diseases', 'Pancreatic tumor', 'Trauma']}, {'name': 'Segmental pancreatic resection', 'type': 'PROCEDURE', 'description': 'Procedure codes: 5-524.0\\*; 5-524-x; 5-524.y', 'armGroupLabels': ['Chronic pancreatitis', 'Extra-pancreatic neoplasm', 'Other diseases', 'Pancreatic tumor', 'Trauma']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data is held and provided by the Federal Statistical Office of Germany and the statistical offices of the federal states. Due to data privacy regulations, data sharing is strictly prohibited by German law. Furthermore, the data was evaluated exclusively within the framework of controlled remote data analysis. This meant that we never had direct access to the raw data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medizinische Hochschule Brandenburg Theodor Fontane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Richard Hunger', 'investigatorAffiliation': 'Medizinische Hochschule Brandenburg Theodor Fontane'}}}}