Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT04724551
Status:
COMPLETED
Last Update Posted:
2021-05-28
First Post:
2021-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Neutrophil-to-Lymphocyte Ratio to Exclude Pancreatic Fistula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D010185', 'term': 'Pancreatic Fistula'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 648}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-26', 'studyFirstSubmitDate': '2021-01-19', 'studyFirstSubmitQcDate': '2021-01-25', 'lastUpdatePostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of clinically relevant pancreatic fistula', 'timeFrame': 'at hospital discharge assessed up to 30 days', 'description': 'Clinically relevant postoperative pancreatic fistula according to the 2016 International Study Group of Pancreatic Surgery definition'}], 'secondaryOutcomes': [{'measure': 'Biological markers', 'timeFrame': 'Postoperative day one and three', 'description': 'Identification of biological markers to exclude clinically relevant postoperative pancreatic fistula'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic fistula', 'Neutrophil-to-Lymphocyte Ratio', 'Pancreatoduodenectomy'], 'conditions': ['Pancreas Neoplasm']}, 'descriptionModule': {'briefSummary': 'There is still no consensus on whether drain fluid amylase (DFA) level, C-reactive protein (CRP) level, or complex scores predict clinically relevant postoperative pancreatic fistula (CR-POPF). The aim of this study is to determine the accuracy of simple biochemical parameters (leucocytes, neutrophils, lymphocytes, Neutrophil to Lymphocytes Ratio (NLR), at postoperative days 1 and 3) to exclude the diagnosis of CR-POPF.', 'detailedDescription': 'From January 1, 2012 to December 31, 2020, consecutive patients underwent PD performed at Institut Paoli-Calmettes for various pathologies. Data were entered prospectively into a clinical database (NCT02871336).\n\nThe cohort was split into 3 groups:\n\n* a training cohort ;\n* an internal validation cohort (Paoli Calmettes institute);\n* an external validation cohort (Rennes Pontchaillou Hospital).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '3 cohorts, which were as follows: the set of 451 patients was randomly sampled following a ratio 2:1 into a training (n=301) and a validation (n=150) cohort to respectively determine and validate the accuracy, best timing, and cut-off for the surrogate markers, then validated in an external cohort (n=197).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent pancreatoduodenectomy\n\nExclusion Criteria:\n\n* Total pancreatectomy\n* Enucleation'}, 'identificationModule': {'nctId': 'NCT04724551', 'acronym': 'NLR', 'briefTitle': 'The Neutrophil-to-Lymphocyte Ratio to Exclude Pancreatic Fistula', 'organization': {'class': 'OTHER', 'fullName': 'Institut Paoli-Calmettes'}, 'officialTitle': 'The Neutrophil-to-Lymphocyte Ratio at Post-operative Day 3: a Simple Tool to Exclude Clinically Relevant Postoperative Pancreatic Fistula After Pancreatoduodenectomy', 'orgStudyIdInfo': {'id': 'NLR-IPC 2020-058'}}, 'armsInterventionsModule': {'interventions': [{'name': 'pancreatoduodenectomy (PD)', 'type': 'PROCEDURE', 'description': "A pancreaticogastrostomy or -jejunostomy duct-to-mucosa was achieved according to the surgeon's preference and pancreatic texture."}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Olivier Turrini, PD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Paoli-Calmettes- (IPC)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Paoli-Calmettes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}