Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 9:34 AM
Study NCT ID:
NCT04642794
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2020-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Pancreatitis and Thrombosis (PATHRO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019283', 'term': 'Pancreatitis, Acute Necrotizing'}, {'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2020-11-17', 'studyFirstSubmitQcDate': '2020-11-23', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of anticoagulation therapy', 'timeFrame': 'up to 12 months', 'description': 'incidence defined as : the ratio of the number of patients on curative anticoagulant therapy to the number of patients admitted with AP and portosplenomesenteric vein thrombosis during the inclusion period'}], 'secondaryOutcomes': [{'measure': 'evaluate the outcomes of Number of patients admitted for AP with portosplenomesenteric vein thrombosis', 'timeFrame': 'up to 12 months'}, {'measure': 'hospital mortality at D28', 'timeFrame': 'Day 28', 'description': 'evaluate the hospitality mortality at D28 of patients admitted for AP with portosplenomesenteric vein'}, {'measure': 'hospital mortality at D90', 'timeFrame': 'Day 90', 'description': 'evaluate the hospitality mortality at D90 of patients admitted for AP with portosplenomesenteric vein'}, {'measure': 'hospital mortality at 6 months', 'timeFrame': '6 months', 'description': 'evaluate the hospitality mortality at 6 months of patients admitted for AP with portosplenomesenteric vein'}, {'measure': 'hospital mortality at 12 months', 'timeFrame': '12 months', 'description': 'evaluate the hospitality mortality at 12 months of patients admitted for AP with portosplenomesenteric vein'}, {'measure': 'incidence of portal cavernoma', 'timeFrame': 'up to 12 months', 'description': 'evaluate the incidence of portal cavernoma of patients admitted for AP with portosplenomesenteric vein'}, {'measure': 'incidence of type 2 diabetes secondary to AP', 'timeFrame': 'up to 12 months', 'description': 'evaluate the incidence of type 2 diabetes secondary to AP of patients admitted for AP with portosplenomesenteric vein'}, {'measure': 'incidence of occurrence of malabsorption', 'timeFrame': 'up to 12 months', 'description': 'evaluate the incidence of occurrence of malabsorption of patients admitted for AP with portosplenomesenteric vein'}, {'measure': 'incidence of digestive ischemia', 'timeFrame': 'up to 12 months', 'description': 'evaluate the incidence of digestive ischemia of patients admitted for AP with portosplenomesenteric vein'}, {'measure': 'incidence of hepatic ischemia', 'timeFrame': 'up to 12 months', 'description': 'evaluate the incidence of hepatic ischemia of patients admitted for AP with portosplenomesenteric vein'}, {'measure': 'incidence of pancreatic necrosis', 'timeFrame': 'up to 12 months', 'description': 'evaluate the incidence of pancreatic necrosis of patients admitted for AP with portosplenomesenteric vein'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute necrotizing pancreatitis', 'acute pancreatitis', 'pancreas disease', 'anticoagulation', 'anticolagulant therapy', 'bleeding', 'Portosplenomesenteric Vein Thrombosis', 'splanchic venous thrombosis'], 'conditions': ['Acute Necrotizing Pancreatitis', 'Portosplenomesenteric Venous Thrombosis']}, 'descriptionModule': {'briefSummary': 'Severe acute pancreatitis (AP) is a pathology with high morbidity and mortality. Portosplenomesenteric vein thrombosis is a well-known local complication of AP with a variable incidence, which can reach up to 50% in case of severe AP. However, there is no specific recommendation regarding the management of Portosplenomesenteric vein thrombosis. By analogy to all venous thrombosis, the European Society of Gastroenterology recommends curative anticoagulation. However, the efficacy of curative anticoagulation has never been evaluated by prospective studies. In addition, bleeding complications during AP occur in approximately 10% of patients and are associated with a poor prognosis.\n\nThe investigators wish to conduct an observational multi-center study with epidemiologic aims, including all patients admitted for AP and with a diagnosis of portosplenomesenteric vein thrombosis. The aim of this study is to evaluate the therapeutic management of these patients, the efficacy and safety of anticoagulant treatment for the treatment of Portosplenomesenteric vein thrombosis, and their outcomes.', 'detailedDescription': 'The investigators will include prospectively all patients admitted for AP with a computed tomography diagnosis of portosplenomesenteric vein thrombosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients admitted for AP with portosplenomesenteric vein thrombosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Patients (age \\> 18 years) with acute pancreatitis\n* AND a diagnosis on CT injected with portal time of portosplenomesenteric vein thrombosis or laminated veins (without passage of blood flow through the vessel but without visible intraluminal thrombus) will be included.\n\nExclusion Criteria:\n\n* Patient under guardianship\n* Refusal to participate in research\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04642794', 'acronym': 'PATHRO', 'briefTitle': 'Acute Pancreatitis and Thrombosis (PATHRO)', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Management of Portoplenomesenteric Vein Thrombosis in Patients With Acute Pancreatitis : an Observational Study', 'orgStudyIdInfo': {'id': 'MR_PATHRO'}}, 'armsInterventionsModule': {'interventions': [{'name': 'observational study', 'type': 'OTHER', 'description': 'patients admitted for AP with portosplenomesenteric vein thrombosis.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'GARRET Charlotte, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital of Nantes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}