Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:29 PM
Study NCT ID:
NCT04802993
Status:
COMPLETED
Last Update Posted:
2021-03-17
First Post:
2021-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Survival Among Patients With Pancreatic Cancer Depending on Surgical Resection Rate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5123}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-15', 'studyFirstSubmitDate': '2021-03-15', 'studyFirstSubmitQcDate': '2021-03-15', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'A little more than 10 years (from first patient to vital status)', 'description': 'Overall survival among patients aged 70 years and over with pancreatic ductal adenocarcinoma in the pancreatic head'}], 'secondaryOutcomes': [{'measure': 'Severe complications after pancreaticoduodenectomy', 'timeFrame': 'Around 10 years (patients diagnosed between 1 January 2010 and 31 December 2018, latest dismissal from hospital january 2020)', 'description': 'The rate of severe complications among patients aged 70 years and over who had undergone pancreaticoduodenectomy for any reason'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pancreaticoduodenectomy'], 'conditions': ['Pancreatic Ductal Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'The primary aim of this population-based study is to investigate how a high resection rate of pancreaticoduodenectomy affects overall survival among patients aged ≥70 years with pancreatic ductal adenocarcinoma. The secondary aim is to determine if a high resection rate of pancreaticoduodenectomy increases perioperative morbidity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients registered in the Swedish National Registry for tumours in the pancreatic and periampullary region diagnosed with right-sided pancreatic adenocarcinoma or resected with pancreaticoduodenectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed between 1 January 2010 and 31 December 2018\n* Registered in the Swedish National Registry for tumours in the pancreatic and periampullary region\n* Either a diagnosis of pancreatic ductal adenocarcinoma of the pancreatic head or having been resected with pancreaticoduodenectomy\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04802993', 'briefTitle': 'Survival Among Patients With Pancreatic Cancer Depending on Surgical Resection Rate', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'Survival Among Elderly Patients in Sweden With Right-sided Pancreatic Adenocarcinoma Depending on Resection Rate of Pancreaticoduodenectomy', 'orgStudyIdInfo': {'id': '2017/151-31'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All patients with pancreatic ductal adenocarcinoma aged 70 years and older', 'description': 'All patients in the registry aged 70 years and older with right-sided pancreatic ductal adenocarcinoma', 'interventionNames': ['Other: Resection rates']}, {'label': 'All patients with pancreatic ductal adenocarcinoma aged 70-79 years', 'description': 'All patients in the registry aged 70-79 years with right-sided pancreatic ductal adenocarcinoma', 'interventionNames': ['Other: Resection rates']}, {'label': 'All patients with pancreatic ductal adenocarcinoma aged 80 years and older', 'description': 'All patients in the registry aged 80 years and older with right-sided pancreatic ductal adenocarcinoma', 'interventionNames': ['Other: Resection rates']}, {'label': 'All patients resected with pancreaticoduodenectomy, all ages', 'description': 'All patients in the registry resected with pancreaticoduodenectomy during the study period', 'interventionNames': ['Other: Resection rates']}, {'label': 'All patients resected with pancreaticoduodenectomy, aged 70-79 years', 'description': 'All patients in the registry resected with pancreaticoduodenectomy during the study period, aged 70-79 years', 'interventionNames': ['Other: Resection rates']}, {'label': 'All patients resected with pancreaticoduodenectomy, aged 80 years and older', 'description': 'All patients in the registry resected with pancreaticoduodenectomy during the study period, aged 80 years and older', 'interventionNames': ['Other: Resection rates']}], 'interventions': [{'name': 'Resection rates', 'type': 'OTHER', 'description': 'All groups are divided into one high- and one low resection rate group depending on percentage of patients with pancreatic ductal adenocarcinoma resected per county and year (first three groups) and resection rate of pancreaticoduodenectomy per 100 000 inhabitants per county (last three groups)', 'armGroupLabels': ['All patients resected with pancreaticoduodenectomy, aged 70-79 years', 'All patients resected with pancreaticoduodenectomy, aged 80 years and older', 'All patients resected with pancreaticoduodenectomy, all ages', 'All patients with pancreatic ductal adenocarcinoma aged 70 years and older', 'All patients with pancreatic ductal adenocarcinoma aged 70-79 years', 'All patients with pancreatic ductal adenocarcinoma aged 80 years and older']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data cannot be further shared by the researchers but is available on application to the Swedish National Registry for tumours in the pancreatic and periampullary region, provided the application is approved by the Swedish Ethical Review Authority'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass. Professor, senior consultant', 'investigatorFullName': 'Bergthor Björnsson', 'investigatorAffiliation': 'Linkoeping University'}}}}